Director, Regulatory Affairs (Gaithersburg, MD)(Req# 14-100) Vaxin
Summary of Position
The Director, Regulatory Affairs is the regulatory representative on the Product Development Teams providing regulatory support and advice. The Director will facilitate regulatory strategy development and implementation, take the lead on regulatory submissions, and author, review, and coordinate quality submissions to regulatory agencies. The Director will prepare for meetings, teleconferences, and other communications with FDA, educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.
Lead the development of regulatory strategy for Product Development Teams, ensuring that the programs meet quality and safety standards required by patients, health care providers, and regulatory agencies.
Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices.
Provide critical review of all documentation supporting regulatory applications.
Lead the preparation of regulatory submissions to FDA and other regulatory agencies.
Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
Monitor applicable current and new regulatory requirements.
Interact with company partners and consultants on regulatory matters.
Contribute to the regulatory perspective on government proposals and external due diligence activities.
Manage the Regulatory Affairs function, interact and coordinate with Quality functions.
Job Requirements (Essential knowledge, skills and attributes)
Advanced Degree (M.S. or Ph.D. preferred) in a Biological Science.
Minimum of 6 years of regulatory affairs biologics industry experience required, vaccine experience preferred.
Direct interaction experience with FDA required.
Thorough knowledge and practical application of domestic and international regulations including cGMPs, GLP, GCP and ICH.
Excellent leadership, written and oral communication skills.
Vaxin is an equal opportunity employer that values diversity
||19 Firstfield Road |
Gaithersburg, MD 20878
Vaxin Inc. is an emerging vaccine company using non-invasive means to elicit immune responses. Our lead programs are vaccines to prevent disease caused by Influenza (phase I), Anthrax, and Avian Influenza.
Beta Test / Clinical Trials Investors: Redmont Venture Partners All Jobs: at Vaxin
|Headquarters:||19 Firstfield Road|
Gaithersburg, MD 20878
|Company Profile:||The Company's proprietary technology consists of non-replicating adenovirus and bacterial vectors that can deliver antigens non-invasively (to the nasal passages or to the skin) to elicit a protective immune response. The nasal mucosa and the skin contain cells that participate in the body's protection mechanism against disease causing pathogens. Vaxin's technology harnesses this pre-existing feature of our immune system.|
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