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Senior Regulatory Affairs Manager

  • Location: London, Greater London, United Kingdom
  • Type: Temporary
  • Job #22004

Senior Regulatory Affairs Manager

Based in the heart of London, our client is a global pharmaceutical company focused on developing first class therapeutics.

They require a Senior Regulatory Affairs Manager with 5+ years’ experience in Regulatory Affairs in the pharmaceutical or biotechnology industry, to join them initially, on a 12-month contract.

Our client is willing to offer a daily pay rate of up to £500 per day.

Job Reference: BBBH 22004

What will a Senior Regulatory Affairs Manager do?

  • Provide support for marketed products, in the capacity of EU regulatory lead or in support of a products EU regulatory lead.
  • Leading relationships with EMA and other regulatory authorities.
  • Provide support with post-approval submissions.
  • Offer contributions to support product life-cycle strategy.
  • Maintenance of Post-authorization PIP and the submission of modifications and annual reports.
  • Manage Reg planning, preparation, and submission of clinical trials applications for post-approval studies.
  • Provide support commercial and launch activities.

What does the Ideal Candidate look like?

  • 5 years’ + experience in Regulatory Affairs in the pharmaceutical or biotechnology industry, including experience of managing EU centralized licenses and experience of working with EU/UK regulatory agencies/requirements/procedures.
  • Comprehensive understanding of relevant EU regulations and guidelines.
  • Experience with the development and commercial phases of the product lifecycle.
  • Excellent post marketing RA experience and the ability operate independently with global teams.
  • Experience interacting with regulatory authorities, including helping with the preparation for regulatory meetings.
  • Previous experience managing regulatory submissions and ensuring deadlines are met.
  • Experience supporting development of briefing documents.

Benefits?

  • 28 days annual leave (pro-rata) plus paid bank holidays. Competitive Salary.
  • Flexibility for working from home.
  • State of the art modern office.
  • Work Laptop, phone (most roles), and latest tools and technologies.
  • Expanding workforce with options for permanent positions and career progression for top performers.
  • The experience of working with a company that will make your CV stand out from the crowd.

Still interested in this opportunity?
Submit your CV (in a Microsoft Word format) today!
OR
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Please don't hesitate to contact any of our team with any questions you may have on Email: info@allenrec.com or Phone: +44330335171

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