106 Pharmaceutical jobs in Hong Kong

Overview

Regulatory Affairs Consultant (m/f/d) - Pharmaceutical Industry

• Responsible for the preparation and submission of regulatory applications to local health authorities in Singapore and Hong Kong.
• Close collaboration with internal teams to ensure regulatory compliance.
• Conducting market surveillance activities and evaluating changes in the regulatory landscape.
• Building and maintaining relationships with relevant authorities and regulatory bodies.
• Supporting the development and implementation of strategies for the market approval of new products.

• A completed degree in pharmacy, life sciences, or a related field.
• At least 3 years of experience in Regulatory Affairs, ideally with a focus on pharmaceutical products.
• Experience in direct contact with local health authorities in Singapore and Hong Kong.
• Fluent communication in Cantonese is a must.
• In-depth knowledge of regulatory requirements and approval procedures in Asia.
• Independent and solution-oriented working style, combined with excellent communication and teamwork skills.

• Access to further exciting projects with leading pharmaceutical companies.
• Active involvement in our network with the prospect of future employment.
• Personalized support by a dedicated contact person who will assist you individually.
• Opportunity to establish and expand valuable contacts in the pharmaceutical industry.
• Attractive terms that match your qualifications and experience.

INOSOLVE specializes in consulting and supporting companies in the pharmaceutical, biotechnology, and medical device sectors, as well as supporting pharmacies and hospitals. Our offices are located in Vienna, Dubai, Cologne, and Singapore.

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• Seniorität level: Associate
• Employment type: Full-time
• Job function: Quality Assurance, Consulting, and Education
• Industries: Pharmaceutical Manufacturing, Chemical Manufacturing, and Biotechnology Research

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Overview

Join to apply for the (Senior) Medical Science Liaison role at Sandoz .

As the Medical Science Liaison, you are responsible to lead scientific engagement with healthcare professionals, support clinical research, and deliver impactful medical education.

• Engage with Medical Experts (MEs) to educate on medical/scientific information.
• Ensure appropriate identification/mapping of MEs/Key Accounts including identification of opportunities to involve MEs when a specific medical need is identified to provide support.
• Develop and execute ME engagement plans to effectively prioritize and strategically engage MEs aligned with country strategy.
• Respond to unsolicited requests for information from MEs.
• Support Sandoz clinical research programs, optimize trial execution and provide scientific educational support to potential and actual study sites in collaboration with clinical operations.
• Facilitate Investigator Initiated Trial (IIT) process upon investigator request.
• Serve as a medical resource to field matrix colleagues.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt.

• Bachelor’s degree in Pharmacology or Ph. D in Life Sciences, or a related field.
• Minimum of 2 years of experience in a similar Medical Affairs or MSL role.
• Strong knowledge of the pharmaceutical industry, with a clear understanding of the role of Medical Affairs in supporting scientific and medical objectives, particularly within the haematology and oncology therapeutic areas.
• Comprehensive understanding of compliance and regulatory standards relevant to medical engagement and scientific exchange.
• Fluency in English and the local language, both written and spoken, with excellent communication and presentation skills.

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

• Mid-Senior level

• Full-time

• Research, Analyst, and Information Technology

• Pharmaceutical Manufacturing

Join to apply for the Quality Assurance Analyst - Top US Investment/Private Bank! role at Michael Page

2 days ago Be among the first 25 applicants

Join to apply for the Quality Assurance Analyst - Top US Investment/Private Bank! role at Michael Page

• International and dynamic working environment
• Competitive remuneration and benefit packages
  
  
  

• International and dynamic working environment
• Competitive remuneration and benefit packages
  
  
  

• Responsible for quality assurance testing/ compliance testing to assess the quality of the business processes in onboarding, periodic review and trigger event review etc., ensuring these processes comply with internal policies and procedures.
• Validate and summarize quality assurance results in clear and concise language and prepare quality assurance reporting materials and management information.
• Support ad-hoc thematic reviews.
• Work closely with different business stakeholders e.g. operations, Risk and Technology functions etc. to implement remedial action plan to address quality assurance observations.
• Support the quality assurance lead with ad hoc duties
  
  
  

• Bachelor's Degree in Economics, Finance or business management related discipline
• 2-4 years of working experience in quality assurance testing/ compliance testing/ compliance monitoring / audit / consulting within big 4 or private banking industry
• Knowledge in SOW corroboration, Customer Identification Program (CIP) requirements, KYC documentation or private wealth management regulatory requirements is an advantage
• Strong analytical skills and highly attentive to details
• Excellent verbal and written communication skills.
• Highly fluent in English and Chinese
  
  
  

• International and dynamic working environment
• Competitive remuneration and benefit packages
• Stimulating and challenging work with huge exposure
• Medical benefits
  
  
  

• Seniority level Entry level

• Employment type Full-time

• Job function Legal and Consulting
• Industries Financial Services, Accounting, and Banking

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Kowloon City District, Hong Kong SAR 1 week ago

Tsim Sha Tsui, Hong Kong SAR 2 months ago

Kowloon City District, Hong Kong SAR 1 week ago

Kwun Tong District, Hong Kong SAR 1 month ago

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Join to apply for the Clinical Trials Assistant (CTA) (Evergreen) role at IQVIA

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Join to apply for the Clinical Trials Assistant (CTA) (Evergreen) role at IQVIA

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
  
  

• High School Diploma or equivalent Req.
• 3 years administrative support experience.
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.
  
  

• Seniority level Entry level

• Employment type Full-time

• Job function Research, Analyst, and Information Technology
• Industries Pharmaceutical Manufacturing

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Get notified about new Clinical Trial Assistant jobs in Kwai Tsing District, Hong Kong SAR .

Hong Kong SAR HK$13,110.00-HK$13, hours ago

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3 days ago Be among the first 25 applicants

Direct message the job poster from Tigermed

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

• Seniority level Associate

• Employment type Full-time

• Job function Research
• Industries Pharmaceutical Manufacturing

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Islands District, Hong Kong SAR 2 weeks ago

Kwai Tsing District, Hong Kong SAR 2 weeks ago

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Join to apply for the Clinical Research Associate (Hong Kong) role at Fortrea

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Join to apply for the Clinical Research Associate (Hong Kong) role at Fortrea

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Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer

Summary Of Responsibilities

• Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics.
• Ensures audit readiness at site level.
• Acts in the project role of a Lead CRA as assigned.
• General On-Site Monitoring Responsibilities:
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
• Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
• Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare and submit accurate and timely trip reports.
• Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
• Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
• Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
• Track IP shipments and supplies, as needed.
• Track and follow-up on serious adverse events as assigned.
• Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
• Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
• Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
• Present training content for site initiation.
• Assist with training of new employees (e.g., co-monitoring).
• All other duties as needed or assigned.
  
  

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
• Thorough knowledge of monitoring procedures.
• Basic understanding of the clinical trial process.
• Fluent in local office language and in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  
  

• External Candidates:
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND
• A minimum of 2 years of Clinical Monitoring experience.
• Internal Candidates:
• Internal candidates with a minimum of 2 years of Clinical Monitoring experience.
• Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
• Ability to work with minimal supervision.
• Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Good planning, organization, and problem-solving abilities.
• Works efficiently and effectively in a matrix environment.
  
  

• Thorough working knowledge of Fortrea SOPs for site monitoring.
• One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Phase I monitoring experience.
• Life Science or Nursing qualification.
• Specific skills, systems, certifications, and/or licenses preferred.
• Personal characteristics (leadership, problem solving, interpersonal skills).
• Good attention to detail.
• Methodical approach to work.
• Good understanding of medical and clinical research terminology and clinical research processes.
• An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
• Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
• Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
• Focus on Customer.
• Innovate and Change.
• Pursue Scientific and Process Excellence.
• Work with Others.
• Achieve Results.
• Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
• Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
• Good analytical and negotiation skills.
• Experience using e-clinical systems (e.g., clinical trial management system (CTMS)).
• For medical device positions, experience in providing customer service to device end users.
  
  

• Must be able to sit at a computer for long periods of time.
• Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
• Standard office and/or home working environment.
• Clinical Research Unit and hospital environment (administrative only).
• Risk of eye strain.
• Will involve outside of normal office hours as required by the role.
• Travel Requirement is 60% of the time (traveling to study sites).
  
  

• Seniority level Entry level

• Employment type Full-time

• Job function Research, Analyst, and Information Technology

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Get notified about new Clinical Research Associate jobs in Hong Kong SAR .

Kwai Tsing District, Hong Kong SAR 1 week ago

Kwai Tsing District, Hong Kong SAR 1 week ago

Kwai Tsing District, Hong Kong SAR 1 week ago

New Territories, Hong Kong SAR 9 hours ago

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at .

Regulatory Affairs Group

Regulatory Affairs

Professional

Mongkok, Kowloon, Hong Kong

1. Implements compliance with regulatory agency regulations by providing knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements.
2. Completes thorough analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.
3. Applies in-depth knowledge on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets.
4. Identifies opportunities for input on product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.
5. Completes detailed regulatory submissions required for new and existing product approvals and registrations.
6. Communicates Regulatory Affairs interpretation and feedback in support of federal, state, and international regulations by preparing documentation and reports to support internal and external audits.
7. Coaches more junior colleagues in techniques, processes, and responsibilities.
8. Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with the team.

Sales Manager (Healthcare & Pharmaceutical Sales)

We are seeking an experienced Sales Manager with strong exposure in healthcare networks and pharmaceutical sales. The role will lead a sales team, drive business growth, and build strategic partnerships. Competitive salary, attractive incentives, and career progression offered.

About the Role

We are looking for an experienced and results-driven Sales Manager with proven expertise in healthcare networks and pharmaceutical sales . The successful candidate will lead the sales team, drive business growth, and develop strategic relationships across the medical and pharmaceutical sectors.

Responsibilities

• Lead, coach, and motivate the sales team to achieve business objectives and sales targets
• Develop and execute sales strategies to expand market share within healthcare networks and pharmaceutical companies
• Build and maintain strong relationships with key clients and business partners
• Identify new business opportunities and establish long-term partnerships
• Monitor market trends, competitor activities, and provide insights for management decisions
• Collaborate with internal departments to ensure service excellence and client satisfaction

Requirements

• Minimum 5 years of solid sales experience, with at least 2 years in a supervisory or managerial role
• Strong track record in healthcare network and pharmaceutical sales
• Excellent leadership, team management, and negotiation skills
• Strategic thinker with a result-oriented mindset
• Strong communication skills in both English and Chinese (written & spoken)

What We Offer

• Competitive salary package with attractive performance-based incentives
• Leadership role with career progression opportunities
• Professional training and continuous development support
• A collaborative and professional working environment

Heals Healthcare is an equal opportunities employer and welcomes applications from all qualified candidates.

Join to apply for the Regulatory Affairs Specialist (Two Year Contract) role at Roche Diagnostics.

At Roche Diagnostics you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Roche is an Equal Opportunity Employer.

• Managing local regulatory plan in cooperation with other internal stakeholders to ensure our products are registered on timely manner and business objectives are met
• Submitting technical documentation to Regulatory Authorities and securing registration approval in a timely manner
• Maintaining product registration throughout a product’s lifecycle by applying appropriate regulatory change control
• Providing Global RA with real-time information required to maintain key metrics (i.e. submission dates and approval dates for all product registrations)
• Monitoring and communicating new, upcoming & changes to regulations with local stakeholders and Global RA
• Influencing / shaping regulatory landscape/regulations where possible (advocacy)

• A minimum of a B.S. degree in biomedical science, life science or related field, with 2-3 years health-related quality-focused and regulatory experience
• Knowledge of diagnostics is preferable
• Strong interpersonal communication skills
• Self-starter, highly motivated with attention to details
• Excellent command of written and spoken English and Chinese
• Must be able to work independently, by taking general concepts and direction to produce desirable compliant outcomes
• Ability to prioritize multiple tasks and to function effectively