Regulatory Affairs Manager

2 weeks ago

Uxbridge, United Kingdom i-Pharm Consulting Full time

Regulatory Affairs Manager (Inside IR35)

Duration: 12 months (Extention possible)

Location: 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.

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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