Regulatory Affairs Manager

Career Category Regulatory Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Live What you will do Let’s do this. Let’s change the world. In this vital role, you will play a key part in shaping and executing regulatory strategies that support Amgen’s portfolio across the Gulf markets.

The Regulatory Affairs Manager is assigned to products across Gulf (5 markets), plans and executes regulatory strategies for products with medium-complexity programs and medium business impact in the assigned country(ies). The role aligns local regulatory requirements with corporate standards, manages compliant and timely submissions, maintains product labeling and regulatory compliance, and serves as a point of contact with Health Authorities. Key responsibilities and accountabilities Contribute to the local filing plan for Marketing Authorizations and lifecycle maintenance, advising and aligning with the local cross-functional team. With general supervision, execute the filing plan for the assigned country(ies), ensuring submissions are made on time and meet corporate and local regulatory requirements. Provide local regulatory input to product strategies and advise on local mechanisms that may optimize product development and regulatory approvals. Review and approve promotional and non-promotional materials in accordance with applicable procedures and local requirements. Review Patient Support Programs from a regulatory perspective and provide guidance to support compliance with applicable local requirements and company procedures.  Review digital health and software solutions from a regulatory perspective, including assessment of applicable local requirements and regulatory implications.  Gather, assess, and communicate competitive regulatory intelligence relevant to assigned products, therapeutic areas, and markets.  Assess and apply reliance pathways, where applicable, and support the use of Accumulus for relevant regulatory collaboration and submission activities.  Own and maintain the quality, completeness, accuracy, and timeliness of regulatory data in designated systems and tools, including Veeva RIM, the CPP tool, and regulatory intelligence databases. Prepare clear and concise presentations, as requested, on new or updated regulations, regulatory guidelines, and pricing intelligence, highlighting relevant implications, risks, opportunities, and recommended actions for internal stakeholders. Monitor the external regulatory environment, distributor management, trade association developments, national legislation, regulatory policy, and technical guidance; assess and communicate potential impact to relevant local and regional stakeholders. Perform regulatory research to identify relevant histories, precedents, and information that support product development, registration, and lifecycle decisions. Health Authority interactions Act as a point of contact with regulatory agencies in fulfilling local obligations. Participate in and contribute to the preparation and conduct of local Health Authority interactions. Ways of working and collaboration Work closely with cross-functional colleagues in the country, affiliate, or hub to align on strategy and deliver regulatory and business goals. Exchange regulatory information and intelligence with regulatory colleagues and cross-functional teams, providing timely advice on local regulatory considerations. Partner with International Regulatory Leads and Global Regulatory Leads to support development,