Executive Director, Regulatory Affairs CMC

Plan, implement, and manage regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with various teams. Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug products worldwide with the flexibility for post-approval maintenance and lifecycle management of the marketed products. Develop plans for the preparation of CMC meetings with the regulatory agencies, and draft and review regulatory documents for agency meetings. Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all pertinent regulations and guidance documents for pre- and post-approval submissions. As needed, communicate regulatory CMC requirements to team members and advise of implications of the regulatory CMC strategies to CMC development plan and activities. Contribute to scientific discussions and collaborations with scientists to resolve technical and regulatory issues in drug substance synthesis, management of impurities and degradation products, formulation, manufacturing process, and device combination product development at various development stages and product lifecycle management. Stay current with regulatory guidelines and industry standard methodologies to ensure the company's RA CMC activities are aligned with regulatory expectations. Lead and mentor a team of CMC professionals, encouraging a collaborative and high-performance culture.