Regulatory Affairs Manager - China - Beijing
2天前
工作描述
Career Category
RegulatoryJob Description
Regulatory Affairs Manager- China
Reporting to: Head of Regulatory Strategy, China RA
Based in: Beijing
Job Description
- Applying, obtaining and maintaining regulatory approvals for products within Amgen's portfolio, including CTN, MAA, renewal, variations of product's life cycle management.
- Ensure that regulatory submissions are made on time and meet Amgen corporate standards and local regulatory requirements.
- Developing (with manager's guidance) and implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
- Undertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.
- Participate in the local implementation of key Regulatory projects.
- Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen pipeline.
- Provide regulatory support for Therapeutic Areas/Scientific Affairs activities.
- Where applicable, oversee external vendor/contractor relationships.
- Feedback on any Regulatory Intelligence to International Regulatory Affairs
Knowledge and Skills
- Regulatory expertise in national, MRP, centralized and biotechnology products, medical devices
- Interactions with regulatory authorities
- Working with policies, procedures and SOPs
- Knowledge of national legislation and regulations relating to medicinal products
- Understanding of the registration procedures in Europe and US for MAA, variations, extensions and renewals
- Understanding of drug development
- Experience managing regulatory processes
- Scientific / Technical Excellence
- Supervisory Skills
- Communication Skills: Oral and Written
- Team Work
- Negotiation Skills
- Ability to anticipate and prevent potential issues
Basic Qualifications
- Doctorate degree
OR
- Master's degree and 3 years of directly related experience
OR
- Bachelor's degree and 5 years of directly related experience
OR
- Associate's degree and 10 years of directly related experience
Preferred Qualifications:
- Experience in MNCs,
- Experience in biologics
- Experience in medical devices registration field
- Multi-lingual
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