Job Opportunities API

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 .