Director Regulatory Affairs / Sciences

This is an opportunity for an individual to serve as an integral member of development teams and play an instrumental role in the strategic planning and execution of critical development primarily for Early Development programs for Drugs, Biologics and/or Medical Devices. This cross-functional position requires broad knowledge across all facets of development including pre clinical, clinical, manufacturing (CMC), and regulatory.

Responsibilities:

• Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities,
• Lead a robust Early Clinical Development pipeline and shepherd multiple programs through IND filing,
• Plan and execute product development plans in coordination with Sponsor and other team members,
• Develop and implement regulatory strategies, including the identification of gaps or risks, for drugs, biologics and/or devices across a range of therapies,
• Manage IND enabling activities and collaborate cross-functionally, including the facilitation of and partnership with preclinical safety assessment/toxicology, DMPK/bioanalysis, Manufacturing, QC/QA, and clinical teams to achievement of timelines and deliverables,
• Manage and identify key external collaborations that will enhance and/or expedite decisions on projects and/or yield new target opportunities,
• Facilitate oversight and management of vendors, partners, CROs, consultants and contractors in all aspects of project execution,
• Prepare teams for and lead the conduct of milestone development meetings with Regulatory Authorities,
• Provide interpretation of and advice regarding regulations, directives, and guidance,
• Manage IND assembly, managing the strategy, timelines, and implementation of IND assembly plans of eCTD, and filing of IND.

The successful candidate must have:

• Ph.D. in a scientific or technical discipline with 10 years of progressively responsible experience in a pharmaceutical, biotechnology, Medical Device or contract research organization (CRO), including significant experience in a Regulatory Affairs leadership role; OR a Masters degree with 12+ years relevant experience OR a Bachelors' degree with 15+ years of relevant experience. .
• Demonstrated an ability to manage several projects at any given time, to work successfully in a cross-functional and highly collaborative team environment, and to communicate clearly and effectively both verbally and in writing to a variety of audiences.
• Prior experience and success with filing INDs, briefing packages, and amendments required during IND and lifecycles;
• Ability to think strategically and critically to evaluate risks to regulatory product development and approval.
• Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities.
• Experience authoring technical reports, drug discovery documents, and regulatory submissions (Pre-submission, Pre-formal meeting, IND, IDE, NDA, BLA);
• Experience in managing people within a matrixed organizational structure;
• Prior experience and success with filing NDAs, BLAs, 510ks or PMA highly desirable;
• Previous project leadership in drug discovery highly desirable.
• To qualify, applicants must be authorized to work in the United States and should nto require, now or in the future, sponsorship for employment visa status.