Regulatory Affairs Manager

About the Company

Our client is a leading global pharmaceutical organization committed to advancing innovative therapies that improve patient outcomes worldwide. With a strong presence across multiple therapeutic areas, the company combines cutting-edge science with global reach to deliver life-changing treatments.

The Opportunity

We are seeking an experienced Regulatory Affairs Manager to join a dynamic and collaborative regulatory team. This is a key role responsible for driving regulatory strategy and ensuring successful product registrations and lifecycle management across multiple markets.

This position offers the opportunity to work on high-impact products across Vaccines, Oncology, Rare Diseases, and Specialty Care-experience in these therapeutic areas will be highly advantageous.

Key Responsibilities

• Develop and implement regional and global regulatory strategies to support product development and commercialization
• Lead regulatory submissions (CTA/IND/NDA/BLA/MAA) and manage interactions with health authorities
• Ensure timely approvals and compliance with local and international regulations
• Provide regulatory guidance to cross-functional teams including Clinical, R&D, Quality, and Commercial
• Manage product lifecycle activities, including variations, renewals, and labeling updates
• Monitor regulatory intelligence and assess impact on business strategies
• Represent Regulatory Affairs in project teams and governance forums

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred)
• Proven experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
• Strong knowledge of global regulatory frameworks (FDA, EMA, PMDA, or other key agencies)
• Experience in any of the following therapeutic areas is a strong advantage:
  • Vaccines
  • Oncology
  • Rare Diseases
  • Specialty Care
• Excellent project management and stakeholder engagement skills
• Strong communication and influencing abilities
• Ability to work in a fast-paced, matrix environment

What's on Offer

• Opportunity to work with a globally recognized pharmaceutical leader
• Exposure to innovative products and cutting-edge therapies
• Competitive salary and benefits package
• Career development and advancement opportunities within a multinational environment
• Collaborative and inclusive company culture