Regulatory Affairs Manager
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 Amgens portfolio including CTN MAA renewal variations of products life cycle management.
- Ensure that regulatory submissions are made on time and meet Amgen corporate standards and local regulatory requirements.
- Developing (with managers 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
- Masters degree and 3 years of directly related experience
OR
- Bachelors degree and 5 years of directly related experience
OR
- Associates degree and 10 years of directly related experience
Preferred Qualifications:
- Experience in MNCs
- Experience in biologics
- Experience in medical devices registration field
- Multi-lingual
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
