Regulatory Affairs Manager

Job description

Career Category Regulatory 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 .