Responsibilities :

Responsibilities include lead coordination, preparation and assembly of high quality regulatory submissions including IND's and appropriate amendments, CTA's, NDA's, MAA's, and FDA pre-meeting packages in the. Provide regulatory advice and guidance to operational product teams to ensure regulatory programs and submissions meet domestic and international regulatory requirements. Work closely with preclinical, clinical and CMC groups from the initial process of defining regulatory requirements and strategies to the final approval of reports and their inclusion in the regulatory submission documentation. Lead coordination, preparation, assembly and regulatory review of pre-study clinical investigator documentation and IND Safety Reports, including tracking of document approval. Review submissions for regulatory compliance and technical accuracy. Interface with internal departments to ensure timely submissions and to oversee the support of all filings. Serve as primary liaison between the company and FDA Project Managers and Reviewers for individual projects. Significant responsibility for preparation for key meetings with the FDA and other regulatory authorities.

Experience with investigational and approved product(s) desired. Contribute to the development of complex filing systems for product development, clinical study protocols, clinical trial recruitment, and clinical labeling for the U.S. and internationally. Responsible for obtaining worldwide regulatory requirement and guidelines, Summary Basis of Approvals and other publicly available documents. Responsible for up-to-date knowledge of FDA requirements. Strong role in developing and implementing departmental strategy and the training and development of staff.

Experience :

Ideal candidates for this position will possess a Bachelors degree in a scientific discipline with 5 to 7 years experience working in a regulated environment (pharmaceutical or biotechnology) and greater than 5 years of regulatory experience (M.S. in Regulatory Affairs preferred). Regulatory Affairs Certificate (RAC) desired. Previous management experience preferred. Must possess experience with FDA submissions, including IND’s and NDA’s. Working knowledge of FDA regulations as well as requirements for IND’s, NDA’s, Doffs, CTA’s and MAA’s is required. Experience with Canadian or international dossier strategies is desired. Ability to think strategically and tactically and a strong record of accomplishment are essential. Excellent oral and written communication skills are required.

Ability to establish sound working relationships with people in a wide variety of disciplines and backgrounds is important. Proficient in using the Internet and Microsoft Word, PowerPoint, Access and Excel.

Contact:

The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must) Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us to bob.harold@vernascientific.com.

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