Job Title: Senior Manager, Regulatory Affairs
Location: Hanoi, Hà Nội, Vietnam
Category: Consulting
Job Type: Full Time
Posted Date: March 25th, 2025
Job ID: R255752
Salary Estimate: $45,000 – $65,000 per annum (based on market and experience)
About Cencora
At Cencora, our team members are central to our mission to create healthier futures. Every individual’s contribution drives innovation that improves the health of people and animals globally. Join us and make a meaningful difference.
Job Details
PharmaLex, a Cencora company, is expanding its Regulatory Affairs Services across APAC. We are seeking experienced Senior Managers in Regulatory Affairs to support our growing operations.
Key Responsibilities:
Support change applications including administrative, labelling, CMC, and safety-related submissions with appropriate strategies.
Compile dossiers and prepare necessary documents such as local forms, cover letters, and tables of contents.
Review content for CMC, labelling documentation, and justification documents.
Coordinate with relevant functions on variation procedures and respond to deficiency letters related to CMC, Medical Science, and publishing.
Update local product information, including labelling translations.
Ensure regulatory compliance of product information and artworks.
Manage marketing authorization processes such as withdrawal, holder transfers, and licence renewals.
Contribute to Periodic Safety Update Reports (PSUR).
Check invoices related to regulatory authorities.
Request translations and additional documents like QP declarations and GMP certificates.
Maintain regulatory databases including archiving and tracking submissions.
Manage local regulatory requirements and intelligence.
Use NCA electronic systems for submissions where required locally.
Act as primary contact with local Health Authorities on behalf of clients.
Facilitate cross-functional communication related to regulatory strategy, submissions, and lifecycle management activities.
Support the Country RA Head in issue management including quality and safety concerns, stock management, and dossier preparation/submission following local regulations and SOPs.
Represent Regulatory Affairs in internal meetings and committees.
Review promotional materials for regulatory compliance.
Education Requirement
Degree in Life Sciences; Pharmacy degree preferred.
Experience
5 to 10 years of relevant experience in Regulatory Affairs.
Skills and Knowledge
Expertise in lifecycle management of medicinal products and understanding of Health Authority requirements for maintaining product licenses.
Proficiency in regulatory submission strategies to Health Authorities.
Experience in artwork management and supply strategy.
Strong communication skills, coordinating with Medical Affairs, Pharmacovigilance, Supply, and other local functions.
What Cencora Offers
Benefit offerings vary by country and align with local market practices. Eligibility and effective dates may differ depending on agreements and region.
Affiliated Company: PharmaLex Australia
Equal Employment Opportunity:
Cencora provides equal employment opportunities to all applicants and employees without regard to legally protected characteristics. Reasonable accommodations are available for qualified individuals with disabilities.
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