Associate Director Regulatory Affairs

Job Ref: J31458
Sector: Clinical
Sub-sector: Biotech/Life Sciences
Job Type: Permanent
Date Added: 11 April 2019
  • Cambridge, Cambridgeshire, England, UK Cambridge Cambridgeshire UK CB10 1AA
  • Competitive
    ANNUM
  • Neal Panting
  • 01753 589601
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My client, an expanding Biotech Organisation are currently seeking to recruit an Associate Director of Regulatory Affairs to join their Regulatory team. This position plays a key role in the clinical trial submission process. The role will be based from my client's offices in Cambridge.

The role:

My clients development activities are growing rapidly, and they are currently seeking a full-time Regulatory Affairs Associate Director to help drive our rapid development of new therapeutic antibodies initially in inflammation and immuno-oncology. This role will provide exposure to regulatory affairs including in the US, EU and other global markets.

Responsibilities:

  • Provide regulatory affairs guidance and proactive, practical hands-on approach to achieve the required authorisations for local and international CTA's.
  • Regulatory affairs activities with particular focus on regulatory compliance for clinical trials.
  • Develop or establish working relationships with internal and external partners in industry as appropriate to clinical research programmes and business plans.
  • To liaise with external contractors related to regulatory compliant work carried out on behalf of my client to ensure appropriate standards are met
  • To communicate progress and identify risks and issues arising on regulatory issues to the Vice President, Regulatory Affairs and the Development Clinical Trial Team.
  • Contribute to a range of project teams, as required
  • Manage organising and scheduling teamwork to ensure that projects meet agreed regulatory procedural deadlines

Qualifications:

  • Bachelor of Science (BSc) with a second degree preferred
  • Significant industry/biotech experience of early-phase clinical trials within Regulatory affairs.
  • Expert level of knowledge in pre-approval regulatory affairs.
  • Knowledge of Development Good Practices (GxP).
  • Exceptional communication, collaboration and influencing skills.
  • Maintain a high standard of professionalism when representing the Company, both internally and externally.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Neal.Panting@SRG.co.uk or +441753 589626

SRG
11/05/2019 09:17:09
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