Regulatory Affairs Director

18 hours ago

London, Greater London, United Kingdom Park Street People Full time
Job Title: Senior Regulatory Affairs Manager

We are seeking a confident and experienced Regulatory Affairs Manager to develop and define regulatory plans across multiple products in an innovative therapy area.

This is an exciting opportunity to work with a team who strive for excellence, focused on sharing regulatory best practice and guidance throughout the wider business.

As a Regulatory Lead, you will operate centrally, providing strategic guidance across the region, ensuring regulatory deadlines and approvals are met.

The role involves developing high-quality regulatory documents, contributing to product development, and acting as a point of contact between our company and regulatory agencies.

  • Develop, prepare, and ensure accurate regulatory documents for clinical trials and medical products.
  • Contribute regulatory guidance to enhance product development.
  • Sit with project teams, guiding implementation of regulatory strategy.
  • Ensure product development aligns with our company's strategy and global regulatory requirements.
  • Act as a liaison between our company and regulatory agencies.
Key Responsibilities:
  • Promote compliance with regulatory requirements and guidelines.
  • Collaborate with cross-functional teams to achieve regulatory goals.
  • Manage regulatory submissions and maintain accurate records.
Requirements:
  • Significant Regulatory Affairs experience in the pharmaceutical industry.
  • Proven experience as a Regulatory Lead managing at least one product lifecycle.
  • Prior EU regulatory affairs exposure.
  • Able to demonstrate centralised regulatory plan and strategy development.
  • Strong communication and stakeholder management experience.
  • Strategic experience within Regulatory Affairs.
  • Exposure to full cycle and submissions procedures.
  • Knowledge of Regulatory Affairs legislation and procedures.
  • Excellent communication and interpersonal skills.
Estimated Salary:

$125,000 per year

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