We are seeking a highly experienced Senior Regulatory Manager to lead our regulatory affairs team. The individual will be responsible for developing and executing regulatory strategy across global markets, with a strong focus on FDA compliance, product safety evaluation (PSE), and providing expert regulatory guidance for new and existing products.
Requirements
- 5+ years in regulatory affairs, with at least 3–5 years in a leadership/management role.
- Proven track record of working with the FDA and global regulatory bodies.
- Strong experience in regulatory strategy, product safety evaluation (PSE), and market compliance.
- Deep understanding of FDA regulations, including submissions, compliance requirements, and guidance pathways.
- Expertise in U.S. and international regulatory frameworks.
- Strong leadership, influencing, and team management skills.
- Excellent communication and negotiation abilities.
- Bachelor’s degree in Life Sciences, Law, Regulatory Affairs, Engineering, or a related field is preferred.
Benefits
- 25 days holiday plus bank holidays
- Auto Enrolment Pension Scheme
- Staff discount across our brands
- Perks at Work – discounts across partner brands
- Hybrid working
- Free On-site parking
- Supported Studies
- Employee Assistance Program Scheme
- Regular Social Events
- On-site subsidised gym
- Cycle to Work Scheme
- Electric Vehicle Scheme
- Subsidised Travel from Manchester via Zeelo App