Senior Director, Regulatory Affairs
INTERNAL MEDIA NOTICE OF FILING
Employer: Maze Therapeutics Inc.
Position: Senior Director, Regulatory Affairs (93488)
Duties:
Responsible for our development programs from preclinical candidate designation through drug approval. Provide regulatory leadership and guidance to project teams and 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.
Special Requirements: Must have at least 2 years of prior work experience in each of the following:
Supported development programs, provided regulatory expertise and support for development project work including regulatory review for clinical study teams, regulatory submissions and processes.
Led efforts for coordinating content and publishing documents for INDs, Clinical Trial Applications and NDA/MAA, and their associated maintenance.
Led the Regulatory Submission Teams, designed programs for complete and accurate IND/CTA submissions, and ensured that clinical trials are designed to meet regulatory requirements.
Provided 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.
*Telecommuting allowed for this position*
**Must hold Regulatory Affairs Certification (RAC)**
Education: Master’s or foreign equivalent in Regulatory Science, Pharmacy, Life Sciences, or related field
Experience: 10 years of experience in job offered or related occupation
Salary: $304,300.00 - $325,000 / year
Worksite: 171 Oyster Point Blvd, Ste. 300, South San Francisco, CA 94080
Contact: Kimberly Buck, Associate Director, Talent Acquisition
This notice is being provided as a result of the filing of an application for permanent alien labor certification for this relevant job opportunity. Any person may provide documentary evidence bearing on the application to the Certifying Officer, U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210.
Apply To This Job
Employer: Maze Therapeutics Inc.
Position: Senior Director, Regulatory Affairs (93488)
Duties:
Responsible for our development programs from preclinical candidate designation through drug approval. Provide regulatory leadership and guidance to project teams and 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.
Special Requirements: Must have at least 2 years of prior work experience in each of the following:
Supported development programs, provided regulatory expertise and support for development project work including regulatory review for clinical study teams, regulatory submissions and processes.
Led efforts for coordinating content and publishing documents for INDs, Clinical Trial Applications and NDA/MAA, and their associated maintenance.
Led the Regulatory Submission Teams, designed programs for complete and accurate IND/CTA submissions, and ensured that clinical trials are designed to meet regulatory requirements.
Provided 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.
*Telecommuting allowed for this position*
**Must hold Regulatory Affairs Certification (RAC)**
Education: Master’s or foreign equivalent in Regulatory Science, Pharmacy, Life Sciences, or related field
Experience: 10 years of experience in job offered or related occupation
Salary: $304,300.00 - $325,000 / year
Worksite: 171 Oyster Point Blvd, Ste. 300, South San Francisco, CA 94080
Contact: Kimberly Buck, Associate Director, Talent Acquisition
This notice is being provided as a result of the filing of an application for permanent alien labor certification for this relevant job opportunity. Any person may provide documentary evidence bearing on the application to the Certifying Officer, U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210.
Apply To This Job