Global Regulatory Development Lead

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Tbwa ChiatDay Inc Full time

We are seeking a highly motivated and experienced Senior Manager of Regulatory Affairs to join our team at Sail Biomedicines. This role will be responsible for developing and executing our regulatory operations and planning, managing, and tracking regulatory submissions.

Responsibilities:
  • Develop regional regulatory operations that de-risk and accelerate the registration of innovative and established medicines for both US and OUS regulatory agencies.
  • Execute global registration strategies that enhance the likelihood of regulatory approval through the pursuit of novel regulatory pathways and continuous sponsor/regulatory dialog in support of EU and US business priorities.
  • Manage global regulatory development plans for all projects within scope, ensuring clinical trial requirements for global product approval are met.
  • Develop and maintain a submission content plan, tracking documents from authoring to approval, publishing, and QC.
  • Effectively communicate project status, issues, schedule, and accomplishments to various management and stakeholder groups.
Qualifications:
  • BS with 8+ years of industry experience (or equivalent combination of education and experience) with at least 5+ years in regulatory affairs.
  • Submission experience with Nanoparticle based therapeutics, RNA, or Gene Therapy.
  • Expert knowledge of relevant FDA, EU, and ICH guidelines and regulations.
  • Experience as a primary regulatory author for IND, BLA, and CTA documents.
  • Strong experience with CTD format and content regulatory filings.

$160,000 - $240,000 per year

Sail Biomedicines offers a comprehensive compensation package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.



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