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
