Head of Regulatory Affairs

ShapeTX is seeking a highly skilled and experienced leader in regulatory science to join as their Head of Regulatory Affairs. This role will be responsible for developing and implementing regulatory strategies, leading regulatory submissions, liaising with regulatory agencies, and collaborating with cross-functional teams. The Head of Regulatory Affairs will play a pivotal role in ensuring ShapeTX's innovative programmable RNA therapy approaches comply with regulatory guidelines and will oversee regulatory strategy across various functions. This is a unique opportunity to oversee a critical area as ShapeTX transitions from a Research-stage to Clinical-stage company.

• 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
• Liaise 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

• 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 ability to develop and implement regulatory strategies, ensuring compliance with applicable regulations and guidelines
• Experience leading regulatory submissions, including INTERACT briefing books, INDs, CTAs, BLAs, and other relevant documents
• Ability to liaise with regulatory agencies, preparing for and leading meetings to ensure a smooth regulatory process
• Collaborative mindset and ability to work 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
• Experience overseeing and directing external regulatory consultants, vendors, and/or CROs
• Strong leadership skills and ability to build, mentor, and lead a team of regulatory affairs professionals.

• Medical, Dental, and Vision coverage for employees and eligible dependents
• 12 paid Holidays plus a one week winter break at year end
• Competitive paid parental leave benefit
• Annual employee stipend for employees to use however they choose
• Flex Paid Time Off program for vacation, sick leave, and other purposes
• Company paid Long Term Disability
• Eligibility to enroll in voluntary 401k plan, voluntary Life/AD&D, and Voluntary FSA's
• Salary range of $184,000 - $276,000
• Additional compensation may include annual target bonus and/or sign-on bonus, equity grant, and relocation bonus
• Inclusive environment that supports diverse perspectives and experiences