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

• 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