Pharmaceutical Regulatory Lead

7 days ago


Uxbridge, United Kingdom Park Street People Full time
Role Overview

Park Street People is currently looking for a Senior Regulatory Affairs Manager to join their team in Uxbridge. The ideal candidate will be a confident Regulatory Lead with experience in developing and defining regulatory plans across multiple products.

The role involves working closely with the regulatory team and stakeholders to provide centralized regulatory strategy and guidance across the region. This includes developing high-quality regulatory documents, ensuring compliance with global regulatory requirements, and aligning product development with the company's business model.

Responsibilities:

  • Develop regulatory documents needed to support clinical trials and medical products.
  • Contribute regulatory guidance to enhance product development.
  • Provide guidance on implementing regulatory strategy.
  • Ensure product development is aligned 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.

The estimated salary for this role is around £90,000 - £130,000 per annum.



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