Regulatory Affairs Expert

18 hours ago


Uxbridge, United Kingdom Park Street People Full time
Job Description

A global pharmaceutical company in Uxbridge is seeking a Senior Regulatory Affairs Manager to join their team. The estimated salary for this role is around £70,000 - £100,000 per annum.

The ideal candidate will be a confident Regulatory Lead with experience in developing and defining regulatory plans across multiple products. They will work closely with the regulatory team and stakeholders to provide centralized regulatory strategy and guidance across the region.

  • Develop high-quality regulatory documents needed to support clinical trials and medical products.
  • Contribute regulatory guidance to enhance product development.
  • Sit with the project team to provide guidance on implementing regulatory strategy.
  • Align product development with the company's business model and global regulatory requirements.
  • Act as a point of contact between the company and regulatory agencies.

Requirements:

  1. Proven experience as a Regulatory Lead managing at least 1 product lifecycle.
  2. Clear demonstration of experience in developing centralized regulatory plans.
  3. Strong communication and stakeholder management experience.
  4. Previous experience in Regulatory Affairs, particularly within the pharmaceutical industry.
  5. Centralized Regulatory Affairs experience.
  6. Strong strategic experience within Regulatory Affairs.
  7. Exposure to Regulatory Affairs submissions procedures and legislation is advantageous.


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