Vice President, Regulatory Affairs

MOMA Therapeutics is a clinical-stage, next-generation precision medicine company dedicated to targeting highly dynamic proteins that underlie human disease via a small molecule approach, utilizing its proprietary KNOMATIC^TM platform. By focusing on genetically validated targets with high translation potential, MOMA is rapidly advancing its pipeline toward responses in the clinic. The lead candidate recently initiated a phase 1 trial, and a 2^nd IND submission is planned for early in 2025. The company, headquartered in Cambridge, MA, offers innovative science and a collaborative company culture. Now is an exciting time to join MOMA! 

MOMA is seeking a Vice President (VP) of Regulatory Affairs to develop and lead global regulatory strategies for the portfolio of programs, and serve as the primary contact with health authorities.  Reporting into the SVP, Head of Clinical Development, the VP of Regulatory Affairs will provide crucial input to MOMA, helping to advance the pipeline towards approval. 

Responsibilities:

Responsibilities include, but are not limited to:

• Leadership of regulatory affairs
  • Lead the Regulatory Affairs function, ensuring adherence to regulatory standards and requirements for the company
  • Provide key updates and guidance on Regulatory activities to Executive Team and Board of Directors, as needed

• Regulatory strategy & execution
  • Play a core role in project teams, developing global regulatory strategies for drug development programs, including clinical and pre-clinical stage programs.
  • Contribute to the creation of the overall product development strategy and manage the development, monitoring and delivery of Regulatory project plans throughout the life cycle
  • Provide input on development plans, Target Product Profile (TPP) development, risk assessments, resource planning, and other documents as required
  • Balances strategy with execution, in a hands-on leadership role

• Meetings and submissions
  • Serve as primary contact with FDA and other regulatory agencies, leading all communications and meetings
  • Lead regulatory meeting preparation efforts supported by the program team
  • Coordinate and manage regulatory submissions (e.g. INDs, clinical trial applications, marketing applications) in collaboration with multi-disciplinary development teams as well as senior management
  • Ensure on-time, high-quality and regulatory–compliant submissions
  • Liaise with regulatory publishing and other ancillary regulatory functions at CROs and consultants to coordinate regulatory submissions

• Functional leadership
  • Build key infrastructure for Regulatory to support the development, approval, and launch of products
  • Hire and manage direct reports and consultants. This is our first FTE regulatory position. As such, the role is initially an individual contributor position with consultancy support
  • Coach, develop, and mentor other team members. Train others on regulatory requirements as needed
  • Develop and maintain partnerships and networks to support delivery of regulatory goals
  • Forecast budgets and develop department best practices and SOPs

Qualifications:

• Qualifications
  • Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred

• Regulatory experience
  • A minimum of 9 years of Regulatory Affairs experience in the biopharmaceutical industry with at least 3 years of Regulatory experience with oncology programs
  • Experience with early stage highly desired. Experience with Companion Diagnostics a plus, but not required
  • A track record of successful interaction with FDA and other regulatory agencies
  • Experience supporting both early and mid-phase development, including development and filing of associated regulatory submissions
  • Ex-US or global regulatory experience highly desired
  • Some experience with CMC Regulatory a plus
  • Experience with alternative regulatory pathways (e.g. breakthrough designation, priority review, fast track) strongly preferred

• Leadership experience
  • Strong track record working with program teams to advance development assets is essential
  • Previous Regulatory team leadership experienced desired

• Knowledge & skills
  • Must be an experienced, hands-on-problem-solver who can develop a broad vision for a unique regulatory strategy while supporting ongoing activities on a day to day basis
  • Ability to review, understand and explain the regulations and guidance documents to guide project teams
  • In-depth understanding of the drug development, product commercialization and life cycle management processes
  • Outstanding written, oral, organizational, and interpersonal skills
  • Ability to collaborate effectively with internal and external key stakeholders
  • Must be comfortable wearing many hats in a small biotech environment and have a “can do” attitude

This is a onsite position in the Boston area with considerable flexibility. Candidates in the Boston area are highly preferred, and are encouraged to be onsite (3 days per week). Remote candidates elsewhere on the East Coast, or within easy travel of Boston, may be considered and regular travel would be required.