Associate Director, Regulatory Affairs - CMC

Syndax Pharmaceuticals is looking for an Associate Director, Regulatory Affairs - CMC

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role: 

The Associate Director of Regulatory Affairs – CMC will provide regulatory leadership in support of commercial and development programs (biologic and small molecule) at Syndax. The successful candidate will provide strategic Regulatory CMC guidance for development activities necessary to conduct global clinical trials, achieve marketing approval of drug candidates and ultimately support the life cycle of approved products. This includes developing and implementing the strategic plans in collaboration with Quality Assurance and Pharmaceutical Development, ensuring timely preparation, review, and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.

This person represents the Regulatory CMC function on multi-disciplinary product development teams and with external entities. The person in this role serves as a resource to CMC team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through to the initial marketing application, and life cycle management.

Key Responsibilities: 

• Lead CMC regulatory affairs activities for designated programs in line with US, European, ICH, and other applicable requirements.
• Coordinate with Quality Assurance, Pharmaceutical Development and other functional areas to implement CMC regulatory strategy.
• Act as the primary Regulatory CMC representative with external consultants, as necessary, to align Syndax strategies with regulatory requirements.
• Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support clinical trials and marketing applications.
• Represent the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks.
• Ensure that regulatory documents are accurate, complete and verifiable against source documents to confirm compliance with regulatory requirements and traceability.
• Evaluation of manufacturing processes and changes, assessment of regulatory implications and supporting their implementation.
• Maintain current knowledge of the relevant guidelines and regulations and determine applicability to Syndax activities.
• Contribute to and participate in health authority meetings. 

Desired Experience/Education and Personal Attributes: 

• A bachelor’s degree in a life science, an advanced degree is preferred.
• At least 10+ years of CMC regulatory affairs experience; small molecule and biologics experience required. Medical Device and /or Combination Product experience a plus.
• Knowledge and understanding of global regulatory regulations and guidelines.
• Previous experience in the preparation and submission of the CMC components of IND/CTA/NDA/BLA/MAAs.
• Strong interpersonal skills and the ability to deal effectively with representatives across disciplines.
• Ability to work in a cross-functional team environment and manage competing priorities.
• Strong attention to detail and excellent organizational, computer, and documentation skills. 

Location: Syndax’s corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $190,000 - $220,000.

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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