Senior Manager Regulatory Affairs

About the Role

Walker Cole International is seeking a Senior Regulatory Affairs Manager who is looking to progress their career in an exciting innovative pharmaceutical business focused on oncology and rare disease.

As a Senior Regulatory Affairs Manager, you will:

• Lead the development and implementation of regulatory strategies for assigned products throughout the lifecycle, from development through post-marketing.
• Serve as the primary regulatory point of contact for global health authorities, including FDA, EMA, MHRA, and other key agencies.
• Coordinate and prepare high-quality regulatory submissions (e.g., INDs, CTAs, MAAs, NDAs, amendments, supplements).
• Provide regulatory guidance to internal teams including clinical, CMC, quality, and commercial.
• Monitor evolving global regulations and assess their impact on product strategy.
• Contribute to regulatory intelligence and risk mitigation planning.
• Support and mentor junior regulatory staff, fostering a culture of compliance and continuous improvement.

A Senior Regulatory Affairs Manager will bring:

• Bachelor's degree in life sciences, pharmacy, or related discipline (Advanced degree preferred).
• Regulatory Affairs experience in the pharmaceutical or biotech industry, with proven success in leading global submissions.
• Strong knowledge of global regulatory frameworks (FDA, EMA, ICH, etc.).
• Experience working with cross-functional teams in a matrixed environment.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and priorities effectively.
• Leadership experience is strongly preferred.

Senior Manager // Regulatory Affairs // Strategy // Leadership // Global // Oncology // Rare Disease // Life Cycle Management // Post Market // Development // FDA // EMA // ICH