Assc. Director of Regulatory Affairs - Odin Search Group

Position Description

Position Description:

The Associate Director will assist in leading the project teams through the preparation of CMC related regulatory strategies.



Duties:


Provides expertise in translating regulatory requirements into practical, workable plans. Is accountable for assuring availability of complete, current and accurate CMC regulatory status for all biologic programs in clinical development.

The Associate Director will provide regulatory risk assessments and intelligence on major global CMC-related regulatory issues.
Assists in general regulatory affairs and regulatory compliance functions of the company.
May manage the activities of other regulatory affairs staff or contract regulatory support in the performance of assigned duties.
Responsibilities:


Helps develop and implement CMC regulatory strategies to facilitate the progress of Phase I through Phase IV development of biologics and devices.
Organizes and manages regulatory aspects of product development programs.
Serves as regulatory representative for select product development programs, including regulatory liaison with the FDA and other regulatory agencies, as assigned.
Manages, prepares and ensures the timely completion of well-organized, scientifically sound CMC related regulatory submissions (domestic and international), to include INDs, CTAs, BLAs, DMFs, IDEs, PMAs, etc. and required amendments that comply with applicable regulatory requirements.
Reviews technical reports and summary documents (clinical, pharmacology & toxicology, chemistry & manufacturing) for adherence to regulatory guidelines, strategies, and commitments.
Qualifications:


Bachelor’s degree in a scientific discipline. Minimum of 7 years of experience in Regulatory Affairs.
Must have experience with development of biological NMEs. The successful candidate will have a broad understanding of pharmaceutical manufacturing, change control, and distribution systems in the US and offshore.
Expert knowledge of FDA regulations. Direct experience working with FDA chemistry reviewers is desired. Working knowledge of foreign regulations is a plus.
Strong written and verbal communication skills necessary. Must have good negotiation skills, and must be able to communicate verbally and orally with a very high level of proficiency.
Experience in the preparation and submission of INDs, BLAs, annual reports, amendments, and supplements. Knowledge of and/or experience with device regulations a plus.
Needs to have ability to review regulatory and scientific submission documents for accuracy, consistency, completeness and adherence to regulatory requirements.
Proficient use of technology including MS Office Software Package and Internet resources is expected.
Must be able to work successfully within a Regulatory team environment and as an individual contributor, with a high level of professionalism. Managerial experience supervising regulatory professionals is highly desired.

How to Apply

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