What are the responsibilities and job description for the Senior Manager, Regulatory Affairs position at Maze Therapeutics?
We Are Genetic Navigators bringing together passionate, creative and dedicated professionals to join a rapidly growing biotech in our mission to translate novel genetic insights into lifesaving medicines.
We are seeking a Senior Manager, Regulatory Affairs to provide strategic and technical regulatory leadership for assigned development programs, from preclinical candidate designation through drug approval. This individual will work within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations. Reporting to the Head of Regulatory Affairs, the Senior Manager will be a key member of the development team and work closely with functional leads and external stakeholders to ensure regulatory success.
Your role in navigating the Maze:
- Represents Regulatory Affairs for assigned programs, providing regulatory guidance and support in global development planning and implementation of regulatory strategy while ensuring compliance with applicable regulations
- Plans and manages regulatory activities related to assigned projects that span technical areas including clinical, nonclinical, and CMC
- Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities
- Arranges, coordinates, and leads the team in planning, preparation, and execution for meetings, teleconferences, and written advice with Health Authorities
- Collaborates effectively with cross-functional teams and external partners, clearly defining regulatory expectations
- Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
- Contributes to the development and maintenance of Regulatory Affairs Department working practices and procedures
Your Navigation Tools:
- Bachelor's degree required. Advanced degree in life sciences preferred.
- Average of 6 years or equivalent relevant experience in regulatory affairs
- Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs
- Experience and knowledge in preparation of IND/CTAs (required) and NDA/BLA/MAAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical)
- Ability to manage multiple projects, prospectively identify potential problems and to partner effectively and positively to solve issues
- Excellent organizational and communication skills, both written and verbal
- Well-prepared, proactive, and comfortable with broad responsibilities in a fast-paced, small company environment