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!
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