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Roivant Sciences // biomedical research
 
Roivant Sciences, 320 West 37th Street, New York City 10018, United States    Posted: Friday, November 01, 2019
 
   
 
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JOB DETAILS
 

Immunovant is a clinical stage biopharmaceutical company committed to developing innovative therapies that not only treat the symptoms, but modify the course, of autoimmune diseases. Our lead asset, IMVT-1401, is in phase 2 clinical development for the treatment of multiple autoimmune diseases, with additional trials expected to start this year.

This highly dynamic team is seeking an entrepreneurial & strategic Director/Sr. Director, Regulatory Affairs CMC to play a key role on our cross-functional R&D team. In this role, you will partner with Immunovant's VP, Regulatory Affairs to lead & contribute to regulatory strategies that expedite development, maximize the probability of success, & mitigate risks. The individual in this position will have the unique opportunity to grow & shape the Regulatory function of a rapid-growth biotech startup.

Key Roles & Responsibilities:

  • Lead & contribute to regulatory strategies that expedite development, maximize the probability of success, & mitigate risks. Ensure global CMC regulatory requirements & strategy are understood by project teams.
  • Play a hands-on role in planning, preparing, & coordinating CMC documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, & responses to Agency queries.
  • Partner & work very closely with internal & external cross-functional team members to ensure achievement of submission deadlines & timely approvals of CMC-related applications
  • Lead interactions with FDA & other Health Authorities for CMC-related topics.
  • Communicate project updates & risks to senior management & stakeholders across the organization. Track regulatory commitments & deliverables.
  • Maintain up-to-date knowledge & understanding of global regulatory requirements.
  • Initiate & contribute to the development of policies & procedures in alignment with GxPs, global regulatory requirements & guidance, & corporate objectives.

Requirements:

  • 10+ years of biopharmaceutical experience, including at least 8 years of direct experience in Regulatory Affairs CMC
  • Demonstrated hands-on experience in biologics drug development, registration, & post-approval life cycle management in a global environment; direct involvement with parenteral products, including devices
  • Comprehensive understanding of CMC product development & in knowledge of applicable global regulations, guidance, & practices
  • Experience in the preparation & submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, & agency queries
  • Prior experience leading interactions with global regulatory authorities on CMC-related issues
  • Strategic & analytical thinker with excellent problem-solving skills & the ability to adapt to changing priorities & deadlines
  • Strong leadership in working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, & external vendors & contract organizations
  • Strong verbal & written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal & external audiences including executive leadership
  • Ability to thrive in a collaborative & fast-paced environment
  • Results-oriented individuals with a strong work ethic & ability to complete projects with minimal oversight; track record of successful IND, CTA, NDA/BLA, & MAA submissions
  • Knowledge of GxP, ICH, FDA, EMA & other global regulations & guidance
  • Attention to detail & an ability to balance analytical & critical-thinking skills to develop data-driven, strategically oriented regulatory proposals & documents
  • Strong experience leading regulatory CMC strategy & input for biologics development programs
  • Bachelor's degree in a relevant scientific discipline; advanced degree (Master's or PhD) in relevant discipline preferred
 
 
 
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