Senior Director, Regulatory Affairs-CMC
Reporting to the Executive Director, Regulatory Affairs – CMC, the Senior Director, Regulatory Affairs‑CMC serves as a spokesperson for Regulatory Affairs‑CMC on programs of major import. The role has full responsibility for planning and strategic implementation of global CMC regulatory submission strategies for initial marketing applications and post‑approval life‑cycle management, and collaborates across functions to develop risk‑based approaches and secure timely approvals.
Responsibilities
- Accountability for global CMC regulatory submission strategies for initial marketing applications and post‑approval life‑cycle management.
- Effective cross‑functional collaboration with project teams and external business partners to develop CMC regulatory strategies, identify regulatory risks, and propose options for risk reduction or risk‑based approaches to achieve timely approvals.
- Represent the department in cross‑functional project teams and establish the framework for managing the preparation, authoring, and maintenance of Quality‑related regulatory submission documents for global clinical trial and marketing applications, as well as post‑marketing variations.
- Conduct technical regulatory authoring, review, and approval of submissions, respond to health authority queries, and prepare health authority engagement briefing packages.
- Support regulatory impact assessment of changes applicable to clinical and/or commercial programs, considering product or program global regulatory strategy and business impact.
- Provide expert review and guidance to team members and cross‑functional partners in the preparation of CMC documentation supporting regulatory submissions and communications, enabling a right‑first‑time approach.
- Maintain knowledge of global regulations and guidance to ensure regulatory compliance, considering evolving regulations, Health Authority expectations, and industry trends to enable flexible or risk‑based approaches.
- Ensure conformance to commitments made with various regulatory agencies and provide regulatory advice to other functional areas.
- Participate in regulatory due diligence activities when required.
Qualifications
- 15+ years of related work experience, including 12+ years in Regulatory Affairs CMC in the biotech/pharmaceutical industry.
- Experience in small molecule drug development and life‑cycle management, with cardiovascular therapeutic area experience as a plus.
- Extensive experience leading the planning, preparation, and execution of CMC/Quality related global submissions.
- Expertise in developing robust global CMC strategies, managing interactions with health authorities (FDA, EMA, and other global agencies), and securing product approvals.
- Experience with eCTD requirements and electronic submissions.
- Strong cross‑functional collaboration, team‑building, and leadership experience, with the ability to navigate complex CMC challenges throughout the product lifecycle.
- Bachelor’s degree in chemistry or a closely related field; an advanced degree is preferred.
- Excellent working knowledge of global regulatory requirements, trends, and the GXPs.
- Solid knowledge of core processes associated with discovery, development, and manufacturing of small molecules.
- Excellent oral and written communication skills, strong organizational skills, and meticulous attention to detail.
Cytokinetics is an Equal Opportunity Employer.
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