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Gyroscope

Director Regulatory Affairs CMC

Regulatory – Ambler, Pennsylvania
Department Regulatory
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

 Gyroscope: Vision for Life

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

Position Summary

The Director, CMC Gene Therapy Regulatory Affairs will manage the CMC regulatory submissions of Gyroscope Therapeutics throughout the lifecycle with minimum supervision, with responsibility for the execution of the regulatory CMC strategy of all submissions.

What we expect the Director, CMC Regulatory Affairs to do:

  • Create regulatory strategy and execute regulatory submissions to support CMC activities of the gene therapy programs in Gyroscope
  • Prepare, author, review, coordinate and manage CMC regulatory submissions, including original IND/IMPD, IND/IMPD amendments, annual reports, agency meeting briefing documents and CMC sections of the BLA/MAA in accordance with applicable regulations
  • Manage all the regulatory submission documents and the associated supporting documents and collaborate closely with Gyroscope CMC and external vendors and collaborators
  • Closely interact with Gyroscope process and analytical development groups, QA, QC and regulatory to deliver successful gene therapy clinical trials and marketing authorizations by providing strategy guidance to the Company on CMC regulatory requirements
  • Act as liaison between Regulatory Affairs and other functional areas at Gyroscope, as well as collaborators and vendors to develop CTD modules
  • Represent Regulatory Affairs in cross-functional team meetings and translate current regulatory requirements and proposed CMC changes into practical, workable submission plans and strategies
  • Research and disseminate regulatory intelligence on trends in regulatory affairs in the CMC gene therapy space and industry standards for CMC Regulatory work.

What we expect to see in your Skills and Experience:

  • Demonstrable experience in Regulatory Affairs with a minimum of 6 years in CMC regulatory. Proven track record in CMC gene therapy is preferred
  • Bachelor's degree in Life Sciences. Advanced Scientific or Process Engineering degree is desirable
  • Ability to manage multiple projects/submissions concurrently.
  • Strong technical writing and editing skills.
  • Comprehensive understanding of FDA, EMA and ICH requirements
  • Experience with delivery of regulatory submissions in eCTD format
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  • Location
    Ambler, Pennsylvania
  • Department
    Regulatory
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor
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