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