New Role ** Snr Manager Regulatory Affairs ** UK ** Central London Area ** Support a diverse pipeline

Reference: ISI535

Expiry Date: 07-02-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

About my client:

My team and I are very excited to bring this opportunity to your attention! Our client is a company that employs thousands of innovative and committed professionals across the globe, who all share a common passion for putting patients first.
The organization has a wide portfolio of products in various therapy areas, which are both marketed and in development. The company is looking to hire a new Senior Manager in Regulatory Affairs to be part of their dynamic and successful team, working closely with regulatory project leads and other project team members in Japan, US, and the EU. They have a clear vision for their pipeline and are not lacking the funding needed to get all their NMEs to market. As a smaller company they can offer you a unique range of duties, where you will be given a high level of responsibility and you will always be rewarded for your efforts and merit.


About the role:

To fill this position, the company is looking for a proactive team player ready to provide EU regulatory guidance, submission strategy and direction to relevant project teams, and rapports at all levels. You would be an individual with proven track record as a liaison who has negotiated with Health Authorities in the past, who knows how to gain acceptance and build trust both internally and externally.


Your duties will include:

  • Implementing the Clinical Trial Regulation (CTR), managing the CTA submission process, leading responses to questions from Health Authorities and ensuring successful approval of CTA applications; providing appropriate oversight and management of CRO vendors.
  • Supporting the preparation of key regulatory documents (e.g. new MAAs, variations, CHMP Scientific Advice and PIPs) and responses to questions from Health Authorities.
  • Assisting with preparation for Health Authority inspections and independent audits.
  • Assumes ownership and responsibility for regulatory projects, working collaboratively with stakeholders internally and externally.
  • Contributing to the development and maintenance of SOPs to reflect best practice and supporting the continual development of optimal processes for the regulatory function of the company.

Our client is offering a hybrid working model, where you will only attend on-site 2 days a week. The package is good for UK standards and includes a competitive salary plus bonus and other company benefits.

 

To Apply!

To apply for this role, please contact me, Ivan Nash on +44 207 801 3388 or press the red “Apply for position” button or send me an email to ivan.nash@advtalent.com and I will reply by return. I will support you throughout the interview and on-boarding experience.

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