Job Details

My client is currently seeking a Senior Director of Regulatory Affairs to join their team in Southern CA (Fully Remote)

Description:

A position is immediately available for a Senior Director of Regulatory Affairs to provide strategic leadership and direction for all company regulatory projects and to oversee the execution of activities to support the company's registration goals. Products under development include cells and exosomes. The Senior Director of Regulatory Affairs will also work with the leadership team to develop long term strategies as well as execute on short term goals for regulatory in accordance with clinical and CMC requirements in alignment with the company's goals. This position will be expected to lead and collaborate with multiple internal teams to ensure that all programs are implemented in accordance with company strategy and in compliance with regulatory agencies, and that overall business strategies are translated to guarantee optimal time to market.

Responsibilities:

• Developing long term strategies and executing short term goals for regulatory, clinical and CMC in alignment with the Company's goals;
• Leading and collaborating with multiple internal teams to ensure that all programs are implemented in accordance with Company strategies and in compliance with regulatory requirements;
• Leading in the preparation of regulatory documents, including, without limitation, IND submissions, marketing applications, meeting requests, briefing documents, and orphan disease and rare disease designation requests;
• Developing robust regulatory strategies and policies;
• Leading regulatory intelligence initiatives;
• Liaising closely with the CMC and clinical teams to ensure all regulatory requirements are met and all information needed for ongoing documentation and registration is produced;
• Representing regulatory affairs on internal project teams;
• Building, managing and effectively leading a team of regulatory personnel and consultants;
• Establishing and managing relationships with external regulatory authorities and maintaining correspondence, communications and other records of interactions;
• Planning, coordinating and leading meetings with regulatory agencies;
• Advising colleagues on regulatory matters and providing guidance in conducting studies that comply with regulatory requirements;
• Coordinating the Company's global regulatory initiatives and strategic development;
• Providing guidance and advice with respect to defining regulatory and overall product and clinical development strategies;
• Assisting in due diligence reviews for potential investors, regulatory, preclinical and clinical activities, as needed;
• Assisting with developing overall product development plans and timelines to ensure scientific rigor and consistency with regulatory requirements; and
• Performing such other Services as may be requested from time to time.

• PhD, M.D. and/or J.D. degree is highly preferred
• 10+ years regulatory affairs experience in a pharmaceutical or biotech company, including senior management experience
• Technical understanding of cell therapy is required
• Excellent communication skills and the ability to work as part of a team are required