Director/Sr. Director, Regulatory Affairs
(Cell or Gene Therapy)
Job Number: #0230
Location: Montgomery County Maryland
Company: Well established (the late 1990s) biopharmaceutical company
Focus: Regenerative therapies - cell therapy
Misc: There are six key management employees listed at this company and we are responsible for the recruitment of three of them
*Note: This is a partial job description. Please contact us for the full description
The Senior Director of Regulatory Affairs will direct regulatory aspects of biopharmaceutical product development programs in various stages of development. The person will ensure that all details are managed efficiently and will have direct experience preparing regulatory submissions for biopharmaceutical products. This individual will work with other departments to provide regulatory strategy, guidance and support for product development. A fundamental measure of success for the position will be meeting regulatory timelines.
Essential Duties & Responsibilities
Develop and execute the Company’s regulatory strategy for all Research & Development ("R&D") and commercial products
Develop and guide CMC regulatory strategy; oversee compliance and serve as a true business partner to Company leadership.
Maintain and further upgrade the core competencies of the Regulatory Affairs ("RA") organization from a technical, commercial and people perspective, which includes establishing organizational commitment and a sense of urgency to drive leading projects through all development stages.
Provide regulatory strategic leadership for all drug development projects, including but not limited, to health authority submissions, interactions and other regulatory requirements in line with corporate objectives and timelines
Provide leadership, and when necessary, contribute hands-on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, amendments, safety reports, and annual updates
Develop budgets and resource forecasts for the Regulatory Team.
Lead all interactions with regulatory agencies
Contributes to the strategic leadership and development of policies, procedures and best practices commensurate with the requirements of a rapidly growing company
Education & Experience
Bachelor’s Degree in a technical or technology related field required. Advanced degree in life sciences is preferred.
Minimum of 15 years’ experience with increasing responsibilities in regulatory affairs and compliance and management of healthcare product development, of which at least ten (10) years shall have been in a senior role, interacting to affect direction and decision-making within development programs and in regulatory agencies. Prior FDA work experience will also be a plus.
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NOTE: This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position. The company we are conducting this search for has the official job description.