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About the Role

Join Johnson & Johnson Innovative Medicine R&D as a Senior Manager, Regulatory Affairs Labeling Product Leader in Toronto, Canada. This hybrid role focuses on driving global labeling strategy, leading target labeling development, and collaborating with cross-functional teams to ensure regulatory compliance and patient-focused advancements in pharmaceutical products.

Responsibilities

• 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 to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products.
• Lead target labeling development.
• Collaborate with functional areas to provide labeling input relevant to clinical study protocols and ensure alignment on endpoints and Patient-Reported Outcomes (PROs), with a label-as-driver approach.
• 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.
• Present at governance meetings, such as Labeling Committee, to seek endorsement of labeling.
• 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.
• Contribute to the continuous improvement of the end-to-end labeling process.
• Support global labeling inspections and audits for assigned products, as applicable.
• Collaborate with external partners.

Requirements

• A minimum of a Bachelor’s degree in a scientific discipline is required.
• 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.
• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
• 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.
• Exceptional verbal and written communication skills.
• Strong organizational, negotiation, and partnering skills.
• Ability to work independently.

Skills

• 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
• Direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products
• Direct experience with target labeling development or New Molecular Entity (NME) submissions
• Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously
• Ability to manage compounds with a certain degree of complexity from a labeling perspective
• Ability to drive a collaborative, customer-focused, learning culture

Location

• Toronto, Ontario, Canada

Work Type

• Hybrid
• Remote

Experience Level

• Senior Manager
• 8 years of professional work experience
• 6 years of direct regulatory labeling content experience

Education Level

• Bachelor’s degree in a scientific discipline
• Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred

Salary/Compensations

• $162,750 to $212,740

Benefits

• Eligible for a discretionary performance bonus

About the Company

• At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases arePrevention, treatment, and cure. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
• Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
• Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Equal Opportunity

• As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.