Senior Regulatory Affairs Specialist
1 day ago
Xcenda, LLC is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, or disability.
Job DescriptionWe are seeking a Senior Manager, Regulatory Affairs to join our team in Malaysia. The successful candidate will be responsible for managing the life cycle of medicinal products, ensuring compliance with Health Authority requirements.
Main Responsibilities:
- Development of regulatory strategies for medicinal products and maintenance of product licences.
- Compilation and submission of regulatory dossiers, including CMC/Labelling documentation.
- Alignment with functions on variation procedures, deficiency letter, e.g., CMC, Medical Science, publishing team.
- Management of local RA requirements (local regulatory intelligence).
- Contact with the local Health Authority on behalf of the client.
Requirements:
- Life Science Degree (Pharmacy degree preferable).
- At least 5-10 years of relevant experience in Regulatory Affairs.
- Experience in artwork management and supply strategy.
We offer a range of benefits that support the well-being of our team members. These include benefit offerings outside the US that vary by country and will be aligned to local market practice.
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