Senior Manager, Regulatory Affairs Labeling Product Leader (Pharmaceutical Labeling)

Location: Hybrid in Toronto, Canada; case-by-case remote work may be approved for cities within Ontario, Canada.

Salary: $162,750–$212,740 base pay, with eligibility for a discretionary performance bonus.

Company

Johnson & Johnson MedTech develops healthcare and pharmaceutical solutions focused on preventing, treating, and curing complex diseases.

What you will do

• Drive global labeling strategies for assigned pharmaceutical products, including target labeling and competitor analysis.
• Lead the development, revision, review, approval, and maintenance of target, primary, and derived labeling documents.
• Partner with global regulatory, clinical, safety, medical affairs, market access, commercial, and other functional teams.
• Lead Labeling Working Groups, strategic labeling discussions, governance meetings, and Health Authority labeling strategy activities.
• Provide guidance on labeling content, processes, timelines, scientific integrity, risks, and mitigation plans.
• Support continuous improvement initiatives, inspections, audits, and resolution of labeling issues.

Requirements

• Bachelor’s degree in a scientific discipline and at least 8 years of professional experience.
• At least 6 years of direct regulatory labeling content experience for pharmaceutical products or an equivalent background.
• Relevant pharmaceutical industry experience and an understanding of pharmaceutical drug development.
• Strong knowledge of worldwide regulatory guidelines and their application to labeling.
• Experience leading project teams in a matrix environment and continuous improvement projects.
• Experience with document management systems, along with exceptional communication, organizational, negotiation, and partnering skills.

Nice to have

• Master’s degree, PhD, or PharmD in a scientific discipline.
• Experience with target labeling development or New Molecular Entity submissions.
• Experience managing multiple products and projects or complex compounds from a labeling perspective.
• Ability to build a collaborative, customer-focused, learning culture.

Culture & Benefits

• Inclusive work environment that respects individual diversity, dignity, and contribution.
• Opportunity to contribute to treatments and cures through Innovative Medicine R&D.
• Hybrid work arrangement with potential Ontario-based remote work subject to approval.
• Discretionary performance bonus eligibility.
• Artificial Intelligence may be used in applicant assessment.