Regulatory Affairs Manager
Career Category
RegulatoryJob Description
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