Head of Regulatory Affairs

Shape Therapeutics

Shape Therapeutics

Seattle, WA, USA
Posted on Tuesday, August 1, 2023

ShapeTX® is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, ShapeTX is developing breakthroughs in RNA editing, next-generation AAVs, and disruptive gene therapy manufacturing. The ShapeTX platform enables pharma innovators to design treatments across a wide range of diseases, including rare genetic disorders as well as debilitating conditions, such as Alzheimer’s, Parkinson’s, and many more. You can find us at shapetx.com and on LinkedIn and Twitter.

At ShapeTX, we are a dynamic team of professionals who are dedicated and passionate about making cures a reality. Through diversity of thought, scientific knowledge, professional rigor and focus we are merging cutting-edge science with extensive drug development expertise to unlock cures to many debilitating diseases.

Shape Therapeutics is headquartered in Seattle, Washington with a satellite site in Boston, Massachusetts.

Position Overview

ShapeTX is seeking a highly skilled, self-driven, and experienced leader in regulatory science to join as our Head of Regulatory Affairs. Reporting to the Head of Clinical Development, this highly impactful, visible, and collaborative Group Head will build and manage the Regulatory function to have a lasting influence on our company’s evolution, development of products, and future patient impact. This Head of Regulatory Affairs will have a pivotal role in ensuring ShapeTX innovative programmable RNA therapy approaches comply with regulatory guidelines and will oversee regulatory strategy collaboratively across functions including clinical, non-clinical, CMC, and quality. This is a unique opportunity to oversee a critical area as ShapeTX navigates the transition from a Research-stage to Clinical-stage company.

What You’ll Do

  • Develop and implement regulatory strategies, ensuring compliance with applicable regulations and guidelines
  • Lead regulatory submissions, including INTERACT briefing books, INDs, CTAs, BLAs, and other relevant documents
  • Liase with regulatory agencies, preparing for and leading meetings to ensure a smooth regulatory process
  • Collaborate with cross-functional teams to ensure regulatory strategies align with company objectives
  • Stay updated on regulatory guidelines and changes, communicating impact to the team, and adjusting strategies as needed
  • Oversee and direct external regulatory consultants, vendors, and/or CROs, as applicable
  • Build, mentor, and lead a team of regulatory affairs professionals

What you Bring

  • Bachelor’s degree in health sciences related field
  • 12+ years experience in regulatory affairs in the pharmaceutical or biotechnology industry
  • 2+ years experience as a functional head of a regulatory affairs group
  • Strong knowledge of current drug development regulations and guidelines including from ICH, FDA, EMA, and others; strong preference for direct experience in novel treatments including cell and gene therapies
  • Demonstrated success in implementing regulatory strategies for novel modalities, including clinical and CMC strategies for advanced therapies
  • Excellent written and communication skills
  • Strong leadership skills and collaborative approach
  • Critical thinking skills
  • Proven record of developing and maintaining successful working relationships with regulatory agencies
  • Flexibility to adapt to a rapidly changing work environment and manage competing demands

Compensation & Benefits

ShapeTX offers a robust benefits package, including but not limited to: Medical, Dental and Vision coverage for employees and their eligible dependents. We provide eligible employees with 12 paid Holidays plus a one week winter break at year end. We are proud to offer a competitive paid parental leave benefit, an annual employee stipend for employees to use however they choose, a Flex Paid Time Off program (allowing flexible PTO for vacation, sick leave, and other purposes) and Company paid Long Term Disability. Employees are eligible to enroll in our Company’s voluntary 401k plan, voluntary Life/AD&D and Voluntary FSA’s.

The salary range for this role is $184,000 - $276,000. The hired applicant's placement within the range is based on qualifications and professional experience. Additional compensation may include annual target bonus and/or sign-on bonus, equity grant and relocation bonus.

We aspire to Shape Life! not only through our science, but also through our commitment to foster an inclusive environment that supports diverse perspectives and experiences.