Regulatory Affairs Manager

Regulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global Regulatory Team (GRT), you'll develop and execute regulatory strategies and ensure compliance with global and regional agencies.Key Responsibilities:Advise the GRT on regional strategy development.Implement regional needs with stakeholders.Supervise regional regulatory leads or support staff.Liaise with regulatory agencies and communicate outcomes.Manage regulatory submissions, ensuring compliance with global and local requirements.Provide guidance on regional regulatory mechanisms to optimize product development.Develop and negotiate regional product labels.Requirements:Strong grasp of regulatory principles and procedures.Prior Pharmaceuticals, Life Sciences or Biotechnology industry background is a must.Experience with policies, procedures, and SOPs.Knowledge of legislation and regulations in medicinal products.Familiarity with regulatory procedures for MAs, CTAs, and post-approval changes.Cultural awareness and sensitivity across regions.This role offers an exciting opportunity to shape regulatory strategies for groundbreaking products in a state-of-the-art environment. Apply now to join us!
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