Regulatory Affairs Manager

Amgen; United Arab Emirates; On-site; AED 180,000 - 300,000; Full time

Job summary

Amgen seeks a Regulatory Affairs Manager to lead regulatory strategies for Gulf markets, ensuring compliance with local and corporate standards across UAE and neighboring countries.

You will oversee submissions, labeling reviews, and health authority interactions, driving timely registrations and lifecycle management. Collaborative cross-functional work is essential to align regulatory plans with business objectives.

Qualifications

• Bachelor's degree in pharmacy or related life sciences; advanced degree preferred.
• Strong knowledge of Gulf region regulatory requirements and lifecycle management.
• Experience with regulatory submissions and labeling reviews in regulated environments.

Responsibilities

• Contribute to local filing plans for Marketing Authorizations and lifecycle maintenance.
• Provide regulatory input to product strategies and advise on development and approvals.
• Review promotional and non-promotional materials for compliance with local requirements.
• Prepare clear presentations on regulations, guidelines, and pricing intelligence for stakeholders.
• Act as point of contact with Health Authorities for local obligations.

Skills

Regulatory affairs knowledge

Cross-functional collaboration

Regulatory strategy

Communication skills

Attention to detail

Risk management

Project management

Education

Bachelor's degree in pharmacy or related life sciences

Advanced degree preferred

Tools

Veeva Vault RIM

CPP tool

Regulatory databases

Job description

RoleThe 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 nbsp
• Review digital health and software solutions from a regulatory perspective including assessment of applicable local requirements and regulatory implications nbsp
• Gather assess and communicate competitive regulatory intelligence relevant to assigned products therapeutic areas and markets nbsp
• Assess and apply reliance pathways where applicable and support the use of Accumulus for relevant regulatory collaboration and submission activities nbsp
• 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 interactionsAct 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

Knowledge and skills

• 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 the 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 Demonstrate ownership accountability proactive issue management supporting timely compliant and business relevant regulatory outcomes

Qualifications and 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 the Gulf UAE Kuwait Qatar Oman and Bahrain legislation and regulations relating to medicinal products is preferred biologicals small molecules and biosimilars Demonstrated proficiency working in regulated document and workflow systems e g Veeva Vault RIM tools and in cross functional matrix environments Skills behaviors detail orientation planning priority management proactive risk management clear written oral communication cultural awareness and a quality mindset