Regulatory Affairs Manager

About the Role

Join Amgen as a Regulatory Affairs Manager located in Dubai, UAE, and play a crucial role in shaping and implementing regulatory strategies to support Amgen’s product portfolio across the Gulf markets (UAE, Kuwait, Qatar, Oman, Bahrain). This role involves managing medium-complexity product programs with moderate business impact, ensuring alignment between local regulatory requirements and corporate standards.

Key Responsibilities

• Develop and contribute to local marketing authorization filing plans and lifecycle management aligned with cross-functional teams.
• Execute filing plans within assigned countries under general supervision, ensuring timely submissions compliant with local and corporate regulations.
• Provide regulatory insights to influence product strategies and optimize development and approval pathways.
• Review and approve promotional and non-promotional materials to meet applicable local and corporate policies.
• Evaluate Patient Support Programs for regulatory compliance with local laws and company procedures.
• Assess digital health and software solutions from a regulatory standpoint, addressing local regulatory implications.
• Collect and analyze competitive regulatory intelligence relevant to products and markets.
• Apply reliance pathways where applicable and utilize tools such as Accumulus to facilitate regulatory collaboration and submissions.
• Ensure accuracy, completeness, and timeliness of regulatory data in systems like Veeva RIM, CPP tool, and intelligence databases.
• Prepare presentations on regulatory updates, pricing intelligence, and guidelines for internal stakeholders highlighting relevant risks and opportunities.
• Monitor and interpret external regulatory environment changes including legislation, policies, and trade association developments and communicate effects to stakeholders.
• Conduct regulatory research to support product development, registration, and lifecycle decision-making.
• Serve as the main liaison with Health Authorities for regulatory compliance and participate in preparation and conduct of agency interactions.
• Collaborate closely with cross-functional and international regulatory teams to align strategy and deliverables.
• Share regulatory intelligence and provide timely advice to teams and partners.
• Support process improvements, mentor junior regulatory representatives, and engage with distributors when necessary.

Candidate Profile

• Demonstrates adaptability, engagement, curiosity, sound judgment, and a solution-focused approach in a fast-changing environment.
• Ability to navigate complex regulatory environments and maintain agility to contribute to patient-centered and business outcomes.
• Excellent written and verbal communication, negotiation, influencing, and teamwork skills with cultural sensitivity.
• Strong planning, priority setting, and proactive risk management capabilities.

Required Qualifications and Experience

• Bachelor’s degree in Pharmacy or related life sciences; advanced degree preferred.
• Between 4 to 8+ years of hands-on experience in Regulatory Affairs, focusing on new product registrations and lifecycle management.
• In-depth knowledge of Gulf region medicinal product legislation for biologicals, small molecules, and biosimilars preferred.
• Proficiency with regulated document and workflow management systems such as Veeva Vault and RIM tools within matrixed environments.

Additional Information

Amgen is committed to equal opportunity employment and accommodates individuals with disabilities throughout the recruitment and employment processes. The company offers competitive total rewards aligned with local industry standards. This is an onsite, full-time position based in Dubai, UAE.