Regulatory Affairs Manager

Role Overview

Regulatory Affairs Manager at Amgen. The role is assigned to products across Gulf markets (5 markets) and supports Amgen's portfolio in the region.

Role Purpose

You will play a key part in shaping and executing regulatory strategies that support Amgen's portfolio across the Gulf markets. In this vital role, you will plan and execute regulatory strategies for products with medium-complexity programs and medium business impact in assigned country(ies), aligning local regulatory requirements with corporate standards while managing compliant and timely submissions.

Key Responsibilities

Filing and Submissions

• Contribute to the local filing plan for Marketing Authorizations and lifecycle maintenance, advising and aligning with the local cross-functional team.
• Execute the filing plan for assigned country(ies) with general supervision, ensuring submissions are made on time and meet corporate and local regulatory requirements.
• Prepare clear and concise presentations on new or updated regulations, regulatory guidelines, and pricing intelligence, highlighting relevant implications, risks, opportunities, and recommended actions for internal stakeholders.

Regulatory Strategy and Product Development

• Provide local regulatory input to product strategies and advise on local mechanisms that may optimize product development and regulatory approvals.
• Perform regulatory research to identify relevant histories, precedents, and information that support product development, registration, and lifecycle decisions.
• Assess and apply reliance pathways, where applicable, and support the use of Accumulus for relevant regulatory collaboration and submission activities.

Compliance and Materials Review

• 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.
• Maintain product labeling and regulatory compliance.

Regulatory Monitoring and Intelligence

• Gather, assess, and communicate competitive regulatory intelligence relevant to assigned products, therapeutic areas, and markets.
• 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.

Data Management and Systems

• 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.

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.

Collaboration and Leadership

• 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, registration, and lifecycle management of assigned products.
• Partner with peers to support consistent application of procedures and ways of working.
• Establish regular contacts and interactions with distributors, where applicable.
• Mentor and advise Local Regulatory Representatives at more junior levels.
• Provide subject-matter expertise to process improvement projects and initiatives.
• Participate in local regulatory process improvements, initiatives, and training.

Qualifications & Experience

• Bachelor's degree in pharmacy or related life sciences (required); advanced degree is an advantage.
• Typically 4–8+ years of Regulatory Affairs experience with strong hands-on new product registration and lifecycle management.
• In-depth knowledge of Gulf legislation and regulations relating to medicinal products (UAE, Kuwait, Qatar, Oman, and Bahrain) is preferred, including biologicals, small molecules, and biosimilars.
• Demonstrated proficiency working in regulated document and workflow systems such as Veeva Vault and RIM tools, and in cross-functional matrix environments.

Skills & Competencies

• Knowledge of regulatory principles, policies, procedures, and standard operating procedures.
• Comprehensive understanding of regulatory activities and how they affect other projects and processes.
• Knowledge of national legislation and regulations relating to medicinal products.
• Awareness of local registration procedures and challenges for Clinical Trial Applications, Marketing Authorizations, and lifecycle management activities.
• Knowledge and experience in the regulatory environment relevant to assigned product area and development stage.
• Understanding of drug development and ability to understand and communicate scientific and clinical information.
• Strong teamwork, written and oral communication, negotiation, and influencing skills.
• Ability to resolve conflicts and develop practical courses of action that support beneficial outcomes.
• Cultural awareness and sensitivity to achieve results across country, regional, and international boundaries.
• Ability to exercise sound judgment, making informed regulatory recommendations with general supervision.
• Detail orientation, planning and priority management, proactive risk management, clear written and oral communication, cultural awareness, and a quality mindset.
• Demonstrate ownership, accountability, and proactive issue management, supporting timely, compliant, and business-relevant regulatory outcomes.

Additional Information

• Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards, in addition to base salary.
• Amgen is an Equal Opportunity employer and will consider applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
• Amgen will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.