Senior Associate Regulatory Affairs

£20 - £28 per hour
  1. Interim/Contract
Uxbridge, London
  1. Regulatory Affairs, CMC
Posted:15/01/2021
BBBH15758

Hobson Prior are looking for a Senior Associate Regulatory Affairs to join a leading biotech organisation who provide pioneering medicines from laboratory to the patient. This position would suit well to someone with the ability to work to strict timelines, working well with stakeholders and timeline pressures. This is a contract position that be can be based in either Uxbridge or Cambridge.

Job Responsibilities:

  • Provides varying levels of product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle.
  • Support may include organizing, managing and executing on regulatory CMC projects and submissions.
  • Tasks may include creating and/or maintaining submission timelines and tables of contents, formatting of documents per style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested.

Key Skills:

  • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project.
  • Strong organizational skills with attention to detail.
  • Excellent time management skills and ability prioritize workload.
  • Project management skills.
  • Adept interpersonal and communication skills (both verbal and written).
  • Ability to work both independently and as a member of a team.

Requirements:

  • Degree in life sciences, biochemistry, or chemistry would be preferred.
  • Experience in biopharmaceutical or pharmaceutical industry is admirable.
  • Familiarity with eCTD structure is preferred.
  • Experience in CMC, including preparation of submissions to Agencies is preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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