Regulatory Affairs Specialist
3 weeks ago
Job Description:
Pay Range: $95.7hr - $110.7hr
Responsibilities:
Candidate will be accountable to support regulatory for Personal Care Brands in NA Consumer Healthcare.
Candidate will be responsible for representing regulatory function to approve promotional material.
Candidate will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making working across regional teams.
Work with regulatory leads through cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, FDA engagement, labeling and advertising.
Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods and medical devices).
Responsible for regulatory approval and maintenance of all product claims compendia for the personal care category.
Ensure that all documents to be submitted to regulators represent the CHC aligned strategy, are complete, accurate, compliant with global and local submission standards and are organized in a manner to facilitate agency review.
Education:
Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred.
Regulatory Certification (RAC) preferred.
Minimum 5 years in Regulatory Affairs, including leadership roles.
Established experience supporting Personal Care and OTC products.
Experience:
Deep knowledge of regulatory requirements to support Personal Care product development and life-cycle management.
Experience in promotional material approval.
Ideally, experience in Consumer Healthcare.
Effective collaboration.
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