US-FL-Sunrise: Regulatory Affairs Specialist

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Date: 21-Apr-2009

Regulatory Affairs Specialist

The Regulatory Affairs Specialist has responsibility for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. This position will report to the Vice President, Clinical Affairs & Physician Relations.

Duties For This Position Include The Following:

* Develop and execute U.S. and international regulatory strategies. * Develop and execute Partial Reimbursement Clinical Trial strategies. * Clearly define the regulatory requirements necessary for regulatory approval to commence clinical trials or to gain approval for commercialization, help shape clincial protocols and submit final reports to regulatory agencies. Work closely with VP of Clinical Affairs & Physician Relations in all of these duties. * Ensure regulatory compliance with all applicable regulations with goal to gain full approval for commercialization in as many markets as possible as supported by the clinical data and filings. This includes gaining the regulatory approvals necessary to enter partial reimbursement clinical registry trials OUS. * Ensure safety of all patients treated with our products and assist with all regulatory filings in this regard. * Keep documents organized and ready for audit and ready for regulatory filings when required ie; an updated (general) foreign regulatory submission package should be ready to send upon request at all times. * Support team activities and assume responsibility for activities, as necessary, to fulfill company needs. * Ensure the quality, content and format of regulatory submissions. * Ensure consistency, completeness and adherence of standards for all submissions. * Serve as the regulatory affairs representative on project teams. * Coordinate and consult with other departments on the content, review and assembly of regulatory documentation. * Manage regulatory project timelines in accordance with project, department and corporate goals. * Assist with the review of promotional materials. * Assist with regulatory compliance in the event of product recall.

Minimum Qualifications:

* B.S. in a scientific discipline, ideally engineering or the physical/biological sciences (M.S. or Ph.D. preferred). * 3+ years of biologic, pharmaceutical or medical device industry experience in regulatory affairs. * Thorough understanding of both domestic and international regulatory requirements. * Strong verbal and written communication, negotiation, and problem solving skills.

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/