Senior Regulatory Associate ** Have you worked on CTAs? Want to learn more about Regs Strategy & Oncology? Cambs, UK

Reference: EB520

Expiry Date: 09-12-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Cambridge
Cambridgeshire
United Kingdom

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Job Description

My client is a clinical-stage biopharmaceutical company developing a novel class of medicines. Their pipeline includes molecules with a unique mechanism of action with systemic immune cell agonists and tumor-targeted immune cell agonists focused on oncology indications with high unmet medical needs. The company is headquartered in Cambs.

They are looking to hire a Senior Regulatory Affairs Associate that will be responsible for the development, execution and tracking of regulatory submissions for the assigned projects and programs, and that will be reporting to the Head of Regulatory Affairs, who is a great manager and people person.

You will like this role if you have previously worked on CTAs and you want to learn more about regulatory strategy and oncology, you will work closely with cross-functional colleagues and you will serve as the Subject Matter Expert for your assigned activities.

Key responsibilities:

  • Responsible for the development, execution and tracking of global regulatory submissions for assigned programs or projects
  • May be responsible for the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned programs or projects
  • May be responsible for monitoring the regulatory landscape to anticipate and adapt to changes that may impact assigned programs or projects
  • Accountable for developing and maintaining internal cross-functional relationships to support the development and execution of regulatory submissions for assigned programs or projects
  • May serve as primary contact with Health Authorities (HA) and/or external collaborators globally for assigned programs or projects
  • May support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities
  • Partners with the Regulatory Affairs and cross-functional colleagues to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and therapeutic-specific issues
  • Responsible for maintaining oversight of current and pending relevant regulatory approvals

There is great potential on this opportunity by joining a small and expanding regulatory team, that will give you global experience, for a truly innovative pipeline that will advance quickly from P1/2 to MAA, with the likelihood of BTD, Prime and an accelerated review of on at least one of their key lead compounds.

Also the packages are good and they will let you work from home some of the time, as long as you can make it to the office regularly. My client will be happy to have a phone call with you before any official interviews, ad explain how he can help you grow in your next career move.

 

To Apply!

To apply for this role, please contact me Javier Monfort or Christian on +44 207 801 3385, or press the red button “Apply for position”, or alternatively, send us a copy of your resume to CV@advtalent.com. We will support you throughout the interview and on-boarding process!

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