Senior Director, Regulatory Affairs

Maze Therapeutics•South San Francisco, CA

1d•Remote

About The Position

Maze Therapeutics Inc. is seeking a Senior Director, Regulatory Affairs to be responsible for development programs from preclinical candidate designation through drug approval. This role involves providing regulatory leadership and guidance to project teams, working collaboratively with cross-functional team members, vendors, and consultants to identify optimal and effective regulatory strategies. The position requires developing and implementing regulatory strategies for clinical development programs in alignment with corporate objectives and regulatory requirements, offering regulatory considerations for the design, conduct, and interpretation of clinical trials, and identifying and assessing regulatory risks associated with development programs while defining strategies to mitigate them. The role also includes staying informed of emerging regulatory trends, guidance documents, and best practices, preparing for and leading successful regulatory meetings and interactions, and leading the authoring, review, and editing of compliant regulatory documents. Additionally, the Senior Director will provide insight and guidance on the implementation of current regulations, assess regulatory risk based on precedence, mentor and develop the Regulatory Affairs team, and lead inspection readiness activities.

Requirements

At least 2 years of prior work experience supporting development programs, providing regulatory expertise and support for development project work including regulatory review for clinical study teams, regulatory submissions and processes.
At least 2 years of prior work experience leading efforts for coordinating content and publishing documents for INDs, Clinical Trial Applications and NDA/MAA, and their associated maintenance.
At least 2 years of prior work experience leading the Regulatory Submission Teams, designing programs for complete and accurate IND/CTA submissions, and ensuring that clinical trials are designed to meet regulatory requirements.
At least 2 years of prior work experience providing regulatory input for clinical development documents e.g., Investigator Brochures, annual Reports and DSURs, Safety Reports, Orphan Drug Application.
Extensive submissions experience at the IND, CTA and NDA/BLA/MAA stages.
Thorough understanding of drug laws such as Federal Food, Drug, and Cosmetic Act of 1938, Orphan Drug Act of 1983, FDA Amendments Act (FDAAA) of 2007, FDA Safety and Innovation Act (FDASIA), 21st Century Cures Act, Directive 2001/83/EC, Directive 2010/84/EU, Directive 2001/20/EC, Regulation (EC) No 726/2004 etc.
Thorough understanding global regulations and requirements such as International Council for Harmonization (ICH) guidelines, FDA/EMA regulations and guidance, etc.
Must hold Regulatory Affairs Certification (RAC)

Responsibilities

Responsible for development programs from preclinical candidate designation through drug approval.
Provide regulatory leadership and guidance to project teams.
Work collaboratively with cross-functional team members, vendors and consultants to identify optimal and effective regulatory strategies for assigned projects.
Develop and implement regulatory strategies for clinical development programs in alignment with corporate objectives and regulatory requirements.
Offer regulatory considerations for the design, conduct, and interpretation of clinical trials.
Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks.
Stay informed of emerging regulatory trends, guidance documents, and best practices related to clinical development and regulatory affairs.
Prepare and lead teams through successful regulatory meetings and interactions.
Lead the authoring, review and editing of high-quality, compliant regulatory documents according to specified timelines and goals.
Provide insight and guidance on the implementation of current regulations and assess regulatory risk based on precedence.
Mentor and develop the Regulatory Affairs team, fostering a culture of continuous improvement and excellence.
Lead inspection readiness activities, including the preparation and coordination of mock and actual inspections.
Contribute to the development and maintenance of Regulatory Affairs Department working practices and procedures.