Senior Manager, Regulatory Affairs

Location
South San Francisco, CA
Posted
Jul 01, 2022
Ref
6033126002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

About Maze Therapeutics

Maze is a clinical-stage biopharmaceutical company harnessing the power of human genetics to transform the lives of patients through the development of a pipeline of novel precision medicines for patients with genetically defined diseases. Maze is leveraging Compass™, a proprietary, end-to-end purpose built platform to advance a pipeline of precision medicines across four disease areas - renal, cardiac, neurological and metabolic diseases. Our flexible business model aims to translate our genetic insights into new therapies for patients as possible.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. 

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.  

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. 

Stand True – Our integrity is foundational; it guides us no matter the obstacle. 

 

Role Description:

The Regulatory Affairs team is 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 includes:

  • 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

Qualifications:

  • 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