Regulatory Affairs Manager

Job Ref: J32289
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 10 June 2019
  • Cambridge, Cambridgeshire, England, UK Cambridge Cambridgeshire UK CB2 8PA
  • Competitive
    HOUR
  • Natasha Rollason
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team. They are looking to recruit a Regulatory Affairs Manager on an initial 12 Month contract basis to their offices in the Cambridge.

The Role:

Regulatory project manager is regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The Regulatory Manager reports to Head of Regulatory and supports the related departments within Centus (clinical operations, clinical supplies, CMC, etc.)

Key Responsibilities:

  • Support Head of Regulatory in delivering regulatory strategy, aligned to the overall development project objectives
  • Oversee regulatory CRO team to ensure timely and high quality delivery of regulatory dossiers in emerging markets such as Brazil, Switzerland, Canada and Taiwan.
  • Serve as point of contact between regulatory CRO team and internal regulatory affair team for regulatory submission and defence activities for above mentioned regions.
  • Oversight activities to include tracking of study objectives, issue resolution and QC of CRO/vendor output.
  • Review of regulatory documents
  • Interface with Project Team members including Clinical Operations, Medical, Clinical Supplies, Drug Safety and Pharmacovigilance and others as appropriate to ensure the Project Team is provided with all required regulatory functional advice and support

Education/Skills:

  • Rest of world submissions submission - Brazil/Australia/Swiss/Canada/Taiwan/Korea are priority countries, experience in these areas will be very desirable.
  • Nation/International travel approx. once every 6 weeks
  • Bachelor degree or equivalent.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@SRG.co.uk or +441753 589673

SRG
10/07/2019 16:25:11
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