Regulatory expertise in national, mrp, centralized and biotechnology products
Interactions with regulatory authorities
Knowledge of national legislation and regulations
Applying, obtaining and maintaining regulatory approvals for products within Amgen’s portfolio, including CTN, MAA, renewal, variations of product’s life cycle management
Job Summary
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.
Undertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.
Matching Summary
Applying, obtaining and maintaining regulatory approvals for products within Amgen’s portfolio, including CTN, MAA, renewal, variations of product’s life cycle management.
Skills & Requirements
Must-have
Regulatory expertise in national, MRP, centralized and biotechnology products
Interactions with regulatory authorities
Knowledge of national legislation and regulations
Understanding of drug development
Experience managing regulatory processes
Nice-to-have
Supervisory skills
Communication skills
Team work
Negotiation skills
Ability to anticipate and prevent potential issues
Key Requirements
Doctorate degree OR Master’s degree and 3 years of directly related experience
Bachelor’s degree and 5 years of directly related experience
Associate’s degree and 10 years of directly related experience