Director, Regulatory Affairs-CMC

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 219,000 - 267,000; Full time

Job summary

A leading biopharmaceutical company in South San Francisco is seeking a Director of Regulatory Affairs-CMC to drive regulatory strategy for clinical-stage programs. The role involves collaboration with cross-functional teams and managing CMC regulatory requirements to support product development and submissions. Candidates should have significant experience in regulatory affairs, particularly in small molecules, and demonstrate strong communication and leadership skills.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Mental Health Support

401(k) with employer match

Generous PTO and holidays

Qualifications

• 10+ years of industry experience in Regulatory Affairs CMC.
• Strong knowledge of global CMC regulations and ICH guidelines.

Responsibilities

• Develop and implement global Regulatory-CMC strategies.
• Oversee planning and review of CMC sections for regulatory submissions.
• Lead health authority interactions on CMC topics.

Skills

Communication

Teamwork

Execution

Adaptability

Education

Master’s or Ph.D. in chemistry

Job description

The Position:

Maze Therapeutics is seeking a Director, Regulatory Affairs-CMC to be a key driver of CMC regulatory strategy for our clinical-stage small molecule programs. In this highly collaborative role, you will provide Regulatory-CMC expertise to support product development, regulatory submissions, and health authority interactions. Reporting to the Vice President of Regulatory and Quality Science, you will work closely with cross-functional teams and external stakeholders to navigate complex regulatory landscapes. This is an opportunity to shape the regulatory path for groundbreaking therapies in a fast-moving environment, applying informed and adaptable approaches to advance development goals.

The Impact You’ll Have:

• Develop and implement global Regulatory-CMC strategies aligned with clinical development plans and long-term regulatory expectations.
• Define CMC regulatory requirements to enable efficient and effective development pathways, balancing speed, risk, and compliance.
• Support product development, manufacturing changes, and quality systems compliance across the product lifecycle.
• Proactively identify risks and collaborate cross-functionally to develop mitigation strategies.
• Partner with CMC, Quality, and Supply Chain teams to incorporate regulatory considerations into manufacturing processes, quality standards, and supply chain strategies.
• Oversee planning, preparation, and review of CMC sections for global regulatory submissions, ensuring high-quality documentation.
• Lead health authority interactions on CMC topics, communicating regulatory strategies effectively to ensure successful outcomes.
• Stay informed of evolving global CMC regulatory trends and translate key changes into actionable strategies.

As a Director, we also expect our leaders to demonstrate the following competencies:

• Communication and Influence: Build communication channels, influence senior management decisions, and address differing opinions respectfully.
• Teamwork and Collaboration: Foster partnerships, proactively resolve issues, and recognize contributions publicly.
• Execution and Results: Address gaps, leverage strengths, maintain focus during change, and remove barriers to success.
• Develop Others and Self: Remove barriers to development, empower decision-making, and stay current with industry trends.

What We’re Looking For:

• Master’s or Ph.D. in chemistry, pharmaceutical sciences, or a related discipline preferred (or equivalent experience).
• 10+ years of industry experience with deep expertise in Regulatory Affairs CMC.
• Strong knowledge of global CMC regulations, ICH guidelines, and regulatory requirements for small molecules.
• Experience working with CMOs and external partners supporting manufacturing and development.
• Background in early-phase clinical development with adaptability through later stages.
• Proven experience in health authority interactions on CMC topics.
• Ability to thrive in a dynamic, fast-paced environment managing multiple projects and regulatory landscapes.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company leveraging human genetics to develop small molecule precision medicines for renal, cardiovascular, and metabolic diseases. Using its Compass platform, Maze identifies and characterizes genetic variants and links them to disease pathways, exemplified by lead programs MZE829 and MZE782 for chronic kidney disease. Based in South San Francisco, Maze is committed to innovative science and patient impact.

Our People

Our team of passionate professionals is dedicated to discovering and delivering transformative medicines. We foster a culture of vision, initiative, and talent development in a supportive environment that encourages creativity and expression, all focused on patient outcomes.

Our Core Values

Further Together: Overcoming challenges through resilience and teamwork.

Impact Obsessed: Embracing boldness, calculated risks, and continuous learning.

Stand True: Guided by integrity in all endeavors.

The annual salary range for employees in the San Francisco Bay Area is $219,000 - $267,000, plus potential performance bonuses. Compensation is benchmarked against industry data, and starting salary depends on experience, skills, and location. This range may be adjusted in the future.

Maze offers comprehensive benefits including medical, dental, vision, mental health, equity, 401(k) with employer match, and generous PTO and holidays.