Director of Compliance and Regulatory Affairs

Nov. 09, 2009 - Nov. 27, 2009
Location:Salt Lake City, UT
Salary Range:DOE
Exempt/Non-Exempt:Exempt
Benefits:Full Benefits Package
Employment Type:Full Time
Department:Research & Developement
Description:POSITION INFO:

Basic Research is looking for a new Director of Compliance and Regulatory Affairs. This Position is primarily responsible for supervising, directing and coordinating various Regulatory and Compliance activities. Basic Research distributes innovative formulations that address the specific needs of consumers – from weight loss to bodybuilding, anti-aging, joint health, skin care, cosmetics, and more.

JOB SUMMARY:

The Director of Compliance and Regulatory Affairs, is responsible for; directing the staff in the regulatory and compliance departments, preparing product dossiers for regulatory submission, providing regulatory input on product development, product information reviews, and regulatory and risk assessments.
Duties:• Complete oversight and management of regulatory and compliance staff, including yearly budgeting, task assignments, training, and interdepartmental coordination
• Compile the necessary technical, regulatory, and legal information necessary to ensure that our products are legally registered with the appropriate authorities in each market where our products are sold
• Work with R&D to make sure the composition of our new product formulas comply with the relevant standards and regulations in each country where the product is planned for introduction
• Respond to inquiries from the applicable regulatory body or in-country consultant(s)
• Assist marketing in developing new labels and advertising that meets various country-specific regulations
• Perform regulatory and risk assessments for pending/proposed legislation which may affect product lines
• Coordinates and participates in writing, preparation, assembly, and maintenance of market authorization and/or investigational submissions (electronic and paper) to regulatory authorities
Qualifications:• Bachelor's in business, marketing or related field, MBA preferred
• Minimum of 7-10 years of regulatory experience – strong preference for extensive experience working with a nutritional and/or cosmetic companies
• 5+ years of management experience managing a regulatory team
• Strong analytical skills and business acumen
• Ability to multi-task and work under pressure
• Good understanding of government regulations and processes as it relates to dietary supplements and cosmetics
• Action-oriented style of work and an ability to consistently exceed agreed upon expectations
• Excellent interpersonal skills and an ability to communicate to international agencies
• Strong communication skills (written and verbal)


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