Senior Manager

2 weeks ago

Cambridge, United Kingdom i-Pharm Consulting Full time

Position: Senior Manager - (EMA) Regulatory Affairs


While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

Location: Either based in Cambridge or Uxbridge

Contract Length: 12-month initial contract

Work Structure: Monday - Friday (Remote) - The team get together around one of the sites, meetings occur in both.

Pay Rate: (Inside IR35)

Senior Manager Regulatory Affairs - Overview:

This role, inside IR35, offers an exciting opportunity to provide regional regulatory support for one or more products. As a crucial member of the Global Regulatory Team (GRT), you will be responsible for developing and executing regional regulatory strategies throughout the product lifecycle and managing effective interactions with regulatory agencies.

The ideal candidate will have a strong track record of supporting diverse regulatory procedures in the EU, including PIPs, variations, IMPDs, and MAAs, and the ability to work independently.

Senior Manager Regulatory Affairs - Responsibilities:

  • Define and advise the GRT on regional regulatory strategy considerations.
  • Ensure European regional needs are well-defined and implemented in collaboration with relevant stakeholders.
  • Develop and execute regulatory strategies and plans, managing regulatory submissions (e.g., clinical trial and marketing applications) for assigned products.
  • Lead the development of regional regulatory documents and meetings, providing regulatory advice on regional requirements and compliance mechanisms.
  • Coordinate and guide company responses to requests from regulatory authorities, such as Responses to Questions (RTQs).
  • Communicate and ensure alignment with proposed regulatory strategies, characterizing and understanding expectations, regulatory risks, and mitigations.
  • Estimate the likelihood of regulatory success and timelines, discussing strategies with the GRT and line management, and communicating outcomes to stakeholders.
  • Maintain awareness of new and developing legislation, regulatory policies, and technical guidance related to the client's products, evaluating, and communicating the impact.
  • Act as the primary contact and build relationships with agency staff on specific product assignments, documenting and communicating details and outcomes of interactions.

Senior Manager Regulatory Affairs - Basic Requirements:

  • Demonstrable experience as a European Regulatory Affairs lead in a therapeutic area, defining and implementing regulatory strategies and executional plans.
  • Practical knowledge of regional regulatory legislation.
  • Experience working with policies, procedures, and SOPs.
  • Experience with national legislation and regional regulations related to medicinal products.
  • Understanding of regional regulatory procedures for CTAs, MAs, post-approval changes, extensions, and renewals.
  • Understanding of drug development processes.
  • Strong knowledge of and experience in the regional regulatory environment for relevant product areas and development stages.
  • Comprehensive understanding of regulatory activities, touchpoints, and their impact on projects and processes.

Senior Manager Regulatory Affairs - Preferred Requirements:

  • Experience working directly with the EMA and Centralised Procedure.
  • Experience in therapeutic areas such as Inflammation, Cardiovascular, Bone.
  • Experience working with biotechnology products.

If you have the experience required for this challenging yet rewarding role, please submit your application including a CV and cover letter to jmanzo@i-pharmconsulting.com or press the "Apply" button below.

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