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Regulatory Affairs Group Regulatory Affairs

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Johnson & Johnson Innovative Medicine R&D; is recruiting for a Senior Manager, Regulatory Affairs Labeling Product Leader.

Remote work options may be considered on a case-by-case basis and if approved by the Company and will be available in all cities within Ontario, Canada.

The Senior

Manager, Regulatory Affairs Labeling Product Leader will be responsible for the following: Drive the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area, their development plans and status and knowledge of labeling aspects for labeling development and target labeling for new products. Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs) to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products. Lead target labeling development.

Provide strategic labeling advice for local labeling in major markets. Analyze relevant competitor labeling,



leverage labeling guidance and trends to develop labeling strategy and content, including risk and mitigation identification and assessment.

Lead Health

Authority (HA) labeling strategy discussions and development of contingency labeling plans and content. Lead the development, revision, review, agreement, and maintenance of target labeling, 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. Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions leading to development of target and primary labeling.

Represent global labeling in Global Regulatory teams and other cross-functional teams, as appropriate. Provide advice and guidance about labeling content, processes, timelines, and scientific integrity. Ensure high quality and compliant labeling documents.

Contribute to the continuous improvement of the end-to-end labeling process. A minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.

A minimum of 8 years of professional work experience is required.



A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required. Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.

Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) An understanding of pharmaceutical drug development is required.

Experience in discussing and communicating scientific concepts is required. Good understanding of worldwide regulatory guidelines and their application for guidance for labeling is required.

Experience leading project teams in a matrix environment is required.

Experience leading continuous improvement projects is required.

Experience working with document management systems is required.

Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred. The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred. The ability to drive a cooperative, customer-focused, learning culture is preferred.

Analytical

Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility Under current guidelines, this position is eligible for a discretionary performance bonus.

- The Company uses Artificial Intelligence in its assessment of applicants. -

📌 Senior Manager, Regulatory Affairs Labeling Product Leader (Toronto)
🏢 Johnson u0026 Johnson Innovative Medicine
📍 Toronto