USA Regulatory Affairs Specialist Team Lead I Scientific

Medical & Science - Pharmaceutical Industry
Adecco Medical & Science is hiring a contract Regulatory Affairs Team Lead I for our Pharmaceutical partner in Bridgewater, NJ.
The anticipated wage for this position is between $102 and $106 hourly. Hourly wage may depend upon experience, education, geographic location, and other factors.

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria
40 hours a week, Hybrid - prefer someone who can be available to work in office on Tuesday and Wednesday when needed. Flexible start and end times but around 9am-5pm. 9 month assignment with possibility to extend. No specific degree requirements but does require a minimum of 5 years experience... Daily expectations/Day in the life: work with brand teams, get new claims to approve for products, review claims to ensure they are in compliance with framework, check fda, suggest a different claim to be permitted if needed, part of approval process for promotional material – advertising campaigns, must be compliant with FDA, deal with multiple brands and product teams
Must Haves/Required Skills:
1. Regulatory Affairs experience with personal care brands cosmetic and OTD
2. Claim approval and promotional material approval
3. Five years experience
4. Cross functional teamwork
5. Microsoft
6. Veeva experience
US Regulatory Affairs Lead – Personal Care Category

SCOPE OF 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
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
Adecco Medical & Science is hiring a contract Regulatory Affairs Team Lead I for our Pharmaceutical partner in Bridgewater, NJ.
The anticipated wage for this position is between $102 and $106 hourly. Hourly wage may depend upon experience, education, geographic location, and other factors.

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria
40 hours a week, Hybrid - prefer someone who can be available to work in office on Tuesday and Wednesday when needed. Flexible start and end times but around 9am-5pm. 9 month assignment with possibility to extend. No specific degree requirements but does require a minimum of 5 years experience... Daily expectations/Day in the life: work with brand teams, get new claims to approve for products, review claims to ensure they are in compliance with framework, check fda, suggest a different claim to be permitted if needed, part of approval process for promotional material – advertising campaigns, must be compliant with FDA, deal with multiple brands and product teams
Must Haves/Required Skills:
1. Regulatory Affairs experience with personal care brands cosmetic and OTD
2. Claim approval and promotional material approval
3. Five years experience
4. Cross functional teamwork
5. Microsoft
6. Veeva experience
US Regulatory Affairs Lead – Personal Care Category

SCOPE OF 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
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

Pay Details:

$102.00 to $106.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adeccousa.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

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