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Senior Manager, Regulatory Affairs Job Opening In Hong Kong, Hong Kong – Now Hiring Cencora


Job description

Our team members are at the heart of everything we do.

At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose.

If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Apply today!

Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.


We are looking for Regulatory Affairs Senior Managers to come join us in Hong Kong!

Responsibilities:

  • Support change applications (Administrative, Labelling, Chemistry, Manufacturing & Controls, Safety) including submission strategy

  • Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents

  • Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents

  • Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry, Manufacturing & Controls, Medical Science, publishing team

  • Update/local Product Information (Labelling translation)

  • Check regulatory compliance of product information/artworks

  • Marketing Authorization withdrawal

  • Marketing Authorization Holder transfer

  • Licence renewal

  • Periodic Safety Update Report contribution

  • Invoice check (e.g. Authority invoices)

  • Request Translation/additional Module 1 documents, e.g. Quality Practices declaration, Good Manufacturing Practices

  • Databases maintenance: archiving, tracking

  • Management of local Regulatory Affairs requirements (local regulatory intelligence)

  • National Competent Authorities electronic systems for submission as locally required

  • Contact with the local Health Authority on behalf of the client

  • Cross-functional communication to all relevant departments in relation to regulatory strategy and submission as well as issues related to Lifecycle Management activities

  • Support of Country Regulatory Affairs Head in issue management (e.g. Quality - Product Quality Controls Standards, Safety issues like stock out situations management, Dear Healthcare Professional Letter preparation coordination and submission in accordance with local regulations and company Standard Operating Procedures, represent Regulatory Affairs in internal meetings and committees)

  • Review of Promotional Materials

  • .

    Education:

  • Life Science Degree (Pharmacy degree preferable)


  • Experience:

  • At least 5-10 years of relevant experience in Regulatory Affairs


  • Skills and knowledge:

  • Experience in the life cycle management of medicinal products and knowledge of the Health Authority requirements for the maintenance of medicinal product licences

  • Regulatory strategy for successful submission to the Health Authority

  • Experience in artwork management and supply strategy

  • Communication with other local functions (Medical Affairs, Pharmacovigilance, Supply)

  • What Cencora offers

    ​Benefit offerings outside the US may vary by country and will be aligned to local market practice.

    The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

    Full time

    Affiliated Companies

    Affiliated Companies: PharmaLex Australia

    Required Skill Profession

    Business Operations Specialists


    • Job Details

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