Senior Manager Regulatory Affairs - new job in Maidenhead, UK

Senior Manager Regulatory Affairs
  • £60 - £64 per Hour
    HOUR
  • Temporary
  • Maidenhead, Berkshire, England, UK Maidenhead Berkshire UK sl6 4ub
Job Ref: J2164886
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 09 June 2022
Senior Manager Regulatory Affairs Maidenhead, England - Hybrid Competative Salary

SRG are partnered with Abbvie, a Biopharmaceutical company who are searching for a Senior Manager Regulatory Affairs based in Maidenhead, England on an initial 6 month basis.

The Role:

  • Supports the implementation of registration strategy for assigned products in the Europe Region. Supports assigned product maintenance and lifecycle management submissions.
  • Supports clinical trials strategy as required.
  • Has some experience with regulatory procedures and contributes to the effective functioning of the Europe Region Regulatory Affairs team.
  • Contribute, as required, in the development of regional processes.
  • Develops and maintains knowledge of regulatory procedures and environment within the region.

Key Responsibilities:

  • Responsible for ensuring that teams and functional groups are provided with clear, constructive regulatory advice and intelligence.
  • Plans and implements regulatory activities in support of lifecycle management and maintenance in the region.
  • Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging.
  • Provides appropriate Europe Region regulatory input to project teams.
  • Ensures planned drug development activities comply with guidelines.
  • Makes recommendations to Global Regulatory and drug development teams.
  • Supports the drug development strategy.
  • Defines Europe Region filing strategy (including CP, MRP, DCP); identifying risks and issues.
  • Responsible for implementing and ensuring effective planning, tracking, archiving of activities.
  • Supports the communication of regulatory strategy in support of new product registration.
  • Follows core GRA policies and procedures.
  • Support implementation of new processes and input into changes in processes.
  • Provides forecasts and actuals and manage in line with regional requirements.
  • Follow all approved regional procedures and guidance.

Skills/Experience Required:

Education and Experience

  • Graduate in Life Sciences in a relevant area.
  • Some knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
  • Prior relevant experience in pharmaceutical industry or Regulatory Affairs

Essential Skills and Abilities

  • Ability to plan and organise workload including managing multiple projects. Ability to work effectively and collaboratively across the Allergan organisation.
  • Good interpersonal and negotiation skills. Good communication skills, both written and verbal (in English).
  • Willingness to travel as necessary.
  • Computer literate

If you are interested in this role or would like more to find of more about this role please contact me on carroline.ramsay@srgtalent.com or on +442039100018.

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
09/07/2022 18:18:09
GBP 60.00 64.00 Hour
Contact Consultant:
Corinne Laurence

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