For The Candidates
Ra Dr Regulatory Affairs-OTC Pharma
NJ
Type:
Full-Time
Category:
Regulatory Affairs
Job ID:
844
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Opportunity Description:
(201) Area Code Northern New Jersey
Job Responsibilities
Responsible for US regulatory activities related to assigned Dietary Supplement Products; this includes products under consideration for development, those in development, and those on the market. Ensure regulatory compliance with regulatory and corporate policies and procedures. Carry out interactions with FDA as well as the creation and development of submissions to FDA, as they relate to dietary supplements
Develop and implement US regulatory strategies for Supplement Products. Provide regulatory assessments, interpretation and implications of FDA regulations on dietary supplements for claims substantiation and labeling requirements. Provide guidance and final approval for US product labeling, claims and promotional material
Direct management supervision of any assigned US Regulatory staff responsible for supporting Supplement products, and for assigned products/projects, coordination of the regulatory activities conducted by staff in the other Regional Regulatory groups and Affiliates who are working on Nutritional products Direct and participate in, when possible and as appropriate, industry activities and direct lobbying of US and, as appropriate, other regulatory authorities to advocate and influence on behalf of Supplements Business. Attend appropriate regulatory/scientific meetings and advisory committee meetings
Actively participate in the development and implementation of the Global Regulatory Influencing Strategy for Supplements Business
Ensure Communication of information on Regulatory and Industry news that affects the Supplements Business. Interpret news and communicate impact to GR&D and the Business Units
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