Director / VP, Regulatory Affairs, CMC (Biologics)
A unique opportunity - strong and diverse pipeline of clinical development
and drug discovery research programs.
Position Description:
The Director / VP will lead the project teams through the preparation of
CMC-related regulatory strategies and submissions,
The Director / VP will provide guidance to the manufacturing and
pharmaceutical development groups on regulatory requirements pertaining to
dosage forms in the therapeutic areas.
Duties:
* Provides expertise in translating regulatory requirements into practical,
workable plans.
* The Director / VP is accountable for assuring availability of complete,
current and accurate CMC regulatory status for all biologic programs in
clinical development.
* Primarily responsible for CMC-related activities pertaining to submissions
to and communications with the FDA and other Regulatory Health Authorities
on assigned projects.
* The Director / VP will liaise with regulatory agencies and facilitate
regulatory communications.
* The Director / VP 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.
* Manage the activities of other regulatory affairs staff and contract
regulatory support in the performance of assigned duties.
Responsibilities:
* 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.
* Recommends regulatory policies to assure adherence to FDA requirements
* Contributes to the modification, development and implementation of company
practices and policies for regulatory affairs
* Scheduling and tracking of project and operational activities for the
regulatory department
* Keeps abreast of all pertinent laws, regulations and guidances and
provides insight on current regulations and guidance documents relevant to
product development projects
* Provides subsequent input on regional regulatory strategies and
implementation activities
* Provides regulatory expertise and policy support for good
pharmaceutical/device practices (GCPs, GMPs, and GLPs)
* Prepares Regulatory Standard Operating Procedures and provides regulatory
review of SOPs from other departments, as necessary
Qualifications:
* Bachelor's degree in a scientific discipline.
*Minimum of 10 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 required.
Client is committed to recognizing individual achievements and contributions
through career advancement.
Email Resume as an attachment in MS WORD format to:
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Elite Recruiting Services, Inc.
858.455.8300 (o)
http://www.elitestaffingsvc.com
Biotechnology | Pharmaceutical | Medical Device
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