Regulatory Affairs Manager

Career Category

Job 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
• 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