Kelly Science, Engineering, Technology & Telecom
Labeling Regulatory Affairs Manager
Kelly Science, Engineering, Technology & Telecom, Trenton, New Jersey, United States
3 days ago Be among the first 25 applicants
Kelly FSP is hiring a Manager, Regulatory Affairs Labeling Product Leader in New Jersey to support our pharmaceutical client in
Raritan or Titusville, NJ.
This position is a hybrid role. Type of Role:
The Manager, Individual Contributor is responsible for the development and maintenance of primary and derived labeling documents. This position ensures quality of primary and derived labeling documents and ensures adequate support for the documents. This role contributes to and participates in the global labeling strategy, including the development of target labeling. Impact (Outcomes) of Decision-Making:
The Manager, Individual Contributor makes recommendations that impact the development, revision, review, agreement, and maintenance of primary and derived labeling documents for the assigned compounds. This position makes decisions that impact the resolution of any labeling issues with potential impact on the primary or derived labeling, and as applicable, to the supporting documentation. The Manager, Individual Contributor provides advice and guidance to team about labeling content, processes, timelines, and scientific integrity. Knowledge/Skills:
Sound scientific knowledge. Understanding of labeling regulations globally (EU, US and International, e.g., Council for International Organizations of Medical Sciences (CIOMS)). Understanding of drug development, including the therapeutic area(s) and individual product knowledge. Awareness of the implications of data on primary labeling documents and derived labeling documents through to the artwork and packaging components. Understanding of what data is required to support a labeling statement and the most appropriate placement of specific text within the labeling. General awareness of the commercial impact of labeling. Competent in the use of labeling business systems (including labeling document management system) and other tools used in support of labeling compliance. Supervision:
The Manager, Individual Contributor is supported and supervised by a Sn Manager, Associate Director, Director . This position works as a team member with colleagues and external contractors across functions. This role influences team members (such as leading the Labeling Working Group meetings), without authority over them and leads discussion at the Labeling Committee. Illustrative Responsibilities:
Participates in the development and maintains primary and derived labeling documents, depending on complexity. Considers competitor labeling when drafting labeling text. Products/document assigned to a Manager vs Sn Manager differentiate in complexity, a manager handling less complex labels and associated tasks. The same applies to illustrative responsibilities listed below (such tasks for more complex products are typically handled by a Sn Manager vs Manager level). Collaborates with SMEs to develop, revise, review, and gain agreement of primary and derived labeling documents through Labeling Working Group (LWG) and Labeling Committee (LC) processes. Collaborates with SMEs to develop, revise, review, and gain agreement of primary and derived labeling documents through Labeling Working Group (LWG) and Labeling Committee (LC) processes. Collaborates with partners (GLO, GRA) to disseminate LC-agreed CCDS, USPI, EUPI and derived labeling documents and supporting documentation. Works with other (functional areas, GLO/TQC, GRA) to ensure high quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents). Liaises with third party companies on product -specific labeling-related issues, as required. Contributes to the continuous improvement of the end to end Global Labeling process. Provides input to and implements the global labeling strategy including the development of target labeling. Supports the GL CoE during audits and inspections and the management of labeling CAPAs as required. Required Experience Bachelor's Degree is required Minimum of 4 years of pharmaceutical experience 3 years of Regulatory Affairs with experience in product labeling/labeling regulations Minimum of 1 year of experience leading teams within a matrix environment with an emphasis on collaborative, customer focused, and learning culture Technical, scientific, or regulatory writing experience Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Kelly Science, Engineering, Technology & Telecom by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles.
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Raritan or Titusville, NJ.
This position is a hybrid role. Type of Role:
The Manager, Individual Contributor is responsible for the development and maintenance of primary and derived labeling documents. This position ensures quality of primary and derived labeling documents and ensures adequate support for the documents. This role contributes to and participates in the global labeling strategy, including the development of target labeling. Impact (Outcomes) of Decision-Making:
The Manager, Individual Contributor makes recommendations that impact the development, revision, review, agreement, and maintenance of primary and derived labeling documents for the assigned compounds. This position makes decisions that impact the resolution of any labeling issues with potential impact on the primary or derived labeling, and as applicable, to the supporting documentation. The Manager, Individual Contributor provides advice and guidance to team about labeling content, processes, timelines, and scientific integrity. Knowledge/Skills:
Sound scientific knowledge. Understanding of labeling regulations globally (EU, US and International, e.g., Council for International Organizations of Medical Sciences (CIOMS)). Understanding of drug development, including the therapeutic area(s) and individual product knowledge. Awareness of the implications of data on primary labeling documents and derived labeling documents through to the artwork and packaging components. Understanding of what data is required to support a labeling statement and the most appropriate placement of specific text within the labeling. General awareness of the commercial impact of labeling. Competent in the use of labeling business systems (including labeling document management system) and other tools used in support of labeling compliance. Supervision:
The Manager, Individual Contributor is supported and supervised by a Sn Manager, Associate Director, Director . This position works as a team member with colleagues and external contractors across functions. This role influences team members (such as leading the Labeling Working Group meetings), without authority over them and leads discussion at the Labeling Committee. Illustrative Responsibilities:
Participates in the development and maintains primary and derived labeling documents, depending on complexity. Considers competitor labeling when drafting labeling text. Products/document assigned to a Manager vs Sn Manager differentiate in complexity, a manager handling less complex labels and associated tasks. The same applies to illustrative responsibilities listed below (such tasks for more complex products are typically handled by a Sn Manager vs Manager level). Collaborates with SMEs to develop, revise, review, and gain agreement of primary and derived labeling documents through Labeling Working Group (LWG) and Labeling Committee (LC) processes. Collaborates with SMEs to develop, revise, review, and gain agreement of primary and derived labeling documents through Labeling Working Group (LWG) and Labeling Committee (LC) processes. Collaborates with partners (GLO, GRA) to disseminate LC-agreed CCDS, USPI, EUPI and derived labeling documents and supporting documentation. Works with other (functional areas, GLO/TQC, GRA) to ensure high quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency (where appropriate) between labeling documents). Liaises with third party companies on product -specific labeling-related issues, as required. Contributes to the continuous improvement of the end to end Global Labeling process. Provides input to and implements the global labeling strategy including the development of target labeling. Supports the GL CoE during audits and inspections and the management of labeling CAPAs as required. Required Experience Bachelor's Degree is required Minimum of 4 years of pharmaceutical experience 3 years of Regulatory Affairs with experience in product labeling/labeling regulations Minimum of 1 year of experience leading teams within a matrix environment with an emphasis on collaborative, customer focused, and learning culture Technical, scientific, or regulatory writing experience Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Kelly Science, Engineering, Technology & Telecom by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles.
New Jersey, United States $90,000.00-$110,000.00 2 weeks ago Manager of Regulatory Affairs - Pesticide Industry
New Jersey, United States $135,000.00-$150,000.00 4 days ago Elmwood Park, NJ $160,000.00-$185,000.00 1 day ago New Jersey, United States $75.00-$80.00 3 days ago Princeton, NJ $135,000.00-$150,000.00 3 weeks ago Regulatory Affairs Supervisor - Cosmetics & Skincare
Totowa, NJ $67,000.00-$72,000.00 3 months ago Associate Director International Regulatory Affairs
Jersey City, NJ $175,000.00-$195,000.00 1 week ago Senior Manager, Global Regulatory Affairs Labeling
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Bridgewater, NJ $160,000.00-$200,000.00 2 days ago Associate Director, Regulatory Affairs Advertising and Promotion
East Hanover, NJ $145,600.00-$270,400.00 6 days ago Montvale, NJ $110,000.00-$120,000.00 2 weeks ago Senior Manager, US Regulatory Affairs and Ingredient Support
Morris Plains, NJ $110,000.00-$135,000.00 4 days ago Titusville, NJ $100,000.00-$172,500.00 6 days ago Summit, NJ $127,075.00-$179,400.00 3 days ago Franklin Lakes, NJ $84,300.00-$138,900.00 1 day ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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