Position Summary

The Manager/Senior Manager, Regulatory Affairs will contribute to the worldwide, strategic direction and expertise to ensure regulatory compliance. The Manager/Senior Manager will be responsible for supporting the initiation and maintenance of global clinical trials. The Manager/Senior Manager, Regulatory Affairs will contribute to the development of regulatory affairs content for global regulatory submissions and regulatory affairs interactions with FDA and other regulatory agencies worldwide.

Essential Duties and Responsibilities

  • Assist in developing and implementing regulatory strategies and plans
  • Plan, prepare and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
  • Manage regulatory documents through internal review and approval processes to ensure cross-functional alignment
  • Ensure regulatory milestones are met to support regulatory approval strategies
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
  • Assist in the preparation of meeting requests, briefing documents and coordinate and prepare teams for meetings with health authorities and collaborate with regulatory authorities
  • Maintain knowledge of pertinent regulations and guidance
  • Coordinate responses to requests for information from regulatory authorities
  • Review advertising and promotional content, sales training and scientific publications for the Regulatory function
  • Recommend regulatory procedures and practices to assure adherence to US and international requirements

Qualifications

  • Bachelor’s Degree in a Life Sciences discipline required
  • Minimum of 5 years of in-depth regulatory experience in pharmaceutical development
  • RAC certification preferred
  • Experience with regulatory submission documents including documents required for CTA, MAA, IND, NDA, PSP/PIP and briefing documents
  • Excellent strategic thinking skills with demonstrated ability to successfully create and implement both short-term and long-term plans to support the department and company
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
  • Ability to effectively engage and influence internal and external leaders, solicit information, persuade others and shape outcomes

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