Senior Manager, Global Labeling Product Leader

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Regulatory Affairs Group

Regulatory Affairs

Professional

Horsham, Pennsylvania, United States of America;
Raritan, New Jersey, United States of America;
Titusville, New Jersey, United States of America

• United States – R-042465
• Belgium, Poland – R-043330
• United Kingdom – R-044318
• Switzerland – R-044319
• Brazil – R-044320

Senior Manager, Global Labeling Product Leader is a hybrid role located in Raritan, NJ;
Titusville, NJ; or Horsham, PA. This leading expert individual contributor is a valuable resource by peers and manages large projects or processes. The role develops methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. The Senior Manager ensures compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations.

• Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents) for assigned compounds.
• Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high quality and compliant labeling documents. This role may collaborate with external partners.
• Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.
• Contribute to the continuous improvement of the end-to-end labeling process.

• Bachelor’s degree in a scientific discipline required; advanced degree (Master’s, PhD, Pharm
  
  D) preferred.
• Minimum 8 years of professional work experience required.
• Minimum 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent required.
• Relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) required.
• Understanding of pharmaceutical drug development required.
• Experience in discussing and communicating scientific concepts required.
• Good understanding of worldwide regulatory guidelines and their application for guidance for labeling required.
• Experience leading project teams in a matrix environment required.
• Experience leading continuous improvement projects required.
• Experience working with document management systems required.
• Experience effectively prioritizing and managing multiple products and projects simultaneously preferred.
• Exceptional verbal and written communication skills required.
• Strong organizational, negotiation, and partnering skills required.
• Ability to work independently required.
• Ability to manage compounds with a certain degree of complexity from a labeling perspective preferred.
• Ability to drive a collaborative, customer-focused, learning culture preferred.

Base pay range for all other U.S. locations is $137,000 to $235,750. The position is eligible for an annual performance bonus in accordance with applicable plans. Bonuses awarded at the company’s discretion on an individual basis.

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