Senior Manager/Director of Regulatory Affairs

4 weeks ago

Uxbridge Greater London, United Kingdom i-Pharm Consulting Full time

Regulatory Affairs Manager (Inside IR35)
Uxbridge, 3 days on-site per week
Hourly 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.
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.
Strong grasp of regulatory principles and procedures.
Prior Pharmaceuticals, Life Sciences or Biotechnology industry background is a must.
Experience with policies, procedures, and SOPs.
Familiarity with regulatory procedures for MAs, CTAs, and post-approval changes.
This role offers an exciting opportunity to shape regulatory strategies for groundbreaking products in a state-of-the-art environment.

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