Regulatory Affairs Director

1 day ago


London, Greater London, United Kingdom Park Street People Full time
Job Title:

Senior Regulatory Lead

Company Overview:

Park Street People is currently working with a global pharmaceutical company based in the UK.

Estimated Salary:

£90,000 - £120,000 per annum

Job Description:

About the Role:

You will be responsible for developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take pride in working to the highest standards, passionate about delivering excellence and focused on sharing regulatory best practice and guidance throughout the wider business.

Key Responsibilities:

  • Develop, contribute and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
  • Contributing regulatory guidance in order to enhance product development.
  • As the regulatory lead, you will sit with the wider project team, providing guidance on how regulatory strategy should be implemented.
  • Ensuring that product development is aligned with the company's business strategy as well as global regulatory requirements.
  • Acting as a point of contact between the company and regulatory agencies while pertaining important information.

Requirements:

  1. Significant Regulatory Affairs experience within the pharmaceutical industry.
  2. Proven experience as a Regulatory Lead managing at least one product end to end lifecycle.
  3. Preferably significant EU regulatory affairs exposure.
  4. Able to clearly demonstrate experience in developing centralised regulatory plans and strategy.
  5. Strong communication and stakeholder management experience.
  6. Strong strategic experience within Regulatory Affairs.
  7. Exposure to Regulatory Affairs full cycle and submissions procedures such as CTA, PIPs, ODDs, and MAAs is advantageous.
  8. Exposure to Regulatory Affairs legislation and procedures.


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