Regulatory Affairs Manager
On-site · Beijing, Beijing, China
Job Summary
Regulatory Affairs Manager responsible for applying, obtaining and maintaining regulatory approvals for Amgen’s portfolio (CTN, MAA, renewals, variations) with compliance to national and European/US requirements. Develop and implement product-related regulatory strategies, manage regulatory processes and activity planning, and conduct interactions with Regulatory Authorities to optimize approvals. Support regulatory intelligence and regulatory projects locally, oversee external vendor/contractor relationships, and ensure alignment with regulatory guidance and SOPs across Therapeutic Areas. Requires expertise in national, MRP, centralized and biotechnology products, and knowledge of drug development, with strong negotiation and communication skills.
Required Qualifications
- Doctorate or Master’s degree with 3+ years of related experience OR Bachelor’s degree with 5+ years of related experience OR Associate’s degree with 10+ years of related experience
- Expertise in national, MRP, centralized and biotechnology products, and medical devices regulatory processes
- Experience with registration procedures in Europe and the US (MAA, variations, extensions, renewals)
- Regulatory submissions experience and interaction with Regulatory Authorities
- Ability to anticipate and prevent regulatory issues
- Strong communication, negotiation, and teamwork skills
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