Regulatory Affairs Senior Manager – at Cencora, Apply Now!
Join Cencora, a global leader in healthcare and regulatory consulting, as a Senior Manager – Regulatory Affairs in Singapore. This role focuses on regulatory submissions, lifecycle management, dossier preparation, and compliance with Health Authority requirements. If you have 5-10 years of regulatory affairs experience in the pharmaceutical industry and expertise in CMC, labeling, and safety change applications, apply today to be part of an innovative and expanding team at Pharmalex, a Cencora company.
About The Comapny
At Cencora, our team members are at the heart of everything we do. 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 Position: Senior Manager, Regulatory Affairs
- Location: Singapore
- Category: Consulting
- Job ID: R255749
Job Details
Pharmalex, a Cencora company, is expanding its Regulatory Affairs Services across APAC. We are looking for Regulatory Affairs Senior Managers to join us!
Key Responsibilities:
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- Support change applications (Administrative, Labelling, CMC, Safety) including submission strategy
- Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
- Content review of CMC/Labelling documentation/Justification documents
- Alignment with functions on variation procedures, deficiency letter, e.g, CMC, Medical Science, publishing team
- Update/local PI (Labelling translation)
- Check regulatory compliance of product information/artworks
- Marketing Authorization withdrawal
- Marketing Authorization Holder transfer
- Licence renewal
- PSUR contribution
- Invoice check (e.g. Authority invoices)
- Request Translation/additional M1 documents, e.g. QP declaration, GMP
- Databases maintenance: archiving, tracking
- Management of local RA requirements (local regulatory intelligence)
- NCA 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 LCM activities
- Support of Country RA Head in issue management (e.g. PQCS Quality, Safety issues like stock out situations management, DHCPL preparation coordination and submission in accordance with local regulations and company SOP, represent RA in internal meetings and committees)
- Review of Promotional Materials
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Education Requirement
Life Science Degree (Pharmacy degree preferred)
Experience
At least 5-10 years of relevant experience in Regulatory Affairs
Skills and Knowledge
Experience in life cycle management of medicinal products and Health Authority requirements
What Cencora Offers
Benefit offerings outside the US may vary by country. Eligibility and effective dates may differ for some benefits.
Keywords: Senior Manager Regulatory Affairs, Cencora Careers, Pharmalex Jobs, Regulatory Submissions, Lifecycle Management, CMC Documentation, Health Authority Compliance, Singapore Jobs, Pharma Regulatory Affairs.
