11 Regulatory Affairs Specialist Team Lead I Jobs in Bridgewater, NJ
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Regulatory Affairs Specialist Team Lead I
$83k-108k (estimate)
Other
1 Month Ago
Integrated Resources Inc is Hiring a Regulatory Affairs Specialist Team Lead I Near Bridgewater, NJ
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Responsibilities:• He/She will be accountable to support regulatory for Personal Care Brands in NA Consumer Healthcare
• He/She will be responsible for representing regulatory function to approve promotional material
• He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making working across regional teams
Duties:• 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/or 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
Knowledge & Expertise:• 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
Job Summary
JOB TYPE
Other
SALARY
$83k-108k (estimate)
POST DATE
06/01/2024
EXPIRATION DATE
10/26/2024
HEADQUARTERS
BONITA SPRINGS, FL
SIZE
50 - 100
FOUNDED
2014
REVENUE
$10M - $50M
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