Senior Manager, Regulatory Affairs Labeling Product Leader

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. 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. Learn more at jnj.com

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.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Toronto, Ontario, Canada

Job Description:

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-095777

Canada - Requisition Number: R-096136

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Regulatory Affairs Labeling Product Leader.  This position is a hybrid role and will be located in Toronto, Canada.

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. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application.  We invite candidates from any location to apply.

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.

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

This role may collaborate with external partners.

Qualifications:

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.) 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.

Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.

Must have exceptional verbal and written communication skills.

Must have strong organizational, negotiation, and partnering skills.

Must have the ability to work independently.

The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.

The ability to drive a collaborative, customer-focused, learning culture is preferred.

#LI-Hybrid

Required Skills:

Preferred 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

The anticipated base pay range for this position is :

Anticipated Pay Range: $162,750 to $212,740

Additional Description for Pay Transparency:

- Under current guidelines, this position is eligible for a discretionary performance bonus. - The Company uses Artificial Intelligence in its assessment of applicants. - This job posting is for an existing position.