Labeling Strategist

BioTalent Canada; Toronto; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading biopharma company in Toronto seeks a Labeling Strategist to manage the labeling for marketed products and those in development. This role involves preparing corporate and regulatory labeling, coordinating the approval processes, and engaging in negotiations with agencies. The ideal candidate has 5 years in the pharmaceutical industry, strong communication skills, and is proactive in problem-solving. Join a future-focused team aiming to improve lives through innovative science.

Benefits

Wide range of health and wellbeing benefits

Supportive team environment

Opportunities for career growth

Qualifications

• In-depth working knowledge of labeling, guidance, and agency regulatory action history is required.
• 5 years pharmaceutical/biotechnology industry experience with 3 years in Labeling.

Responsibilities

• Responsible for labeling of marketed products and projects under development.
• Preparation of corporate, US and EU labeling for products.
• Coordination of labeling review and approvals.

Skills

Excellent written and verbal communication skills

Demonstrated ability to solve problems and proactivity

Ability to work with multifunctional and culturally diverse teams

Organizational skills

Excellent inter-personal skills

Fluent business English

Education

Master’s degree in Life Sciences or Health Sciences or related field

MD or PharmD

Job description

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

The Labeling Strategist will be responsible for the labeling of a portfolio of marketed products and projects under development.

The purpose of this position is to be responsible for the preparation of corporate, US and EU labeling (prescribing information, patient information and other labeling components) for a portfolio of marketed products and projects under development, and to obtain internal company and regulatory agency approvals. Development of labeling for these products is based on study results, safety data, literature data or other information relevant to product or product class; coordination of labeling review and approval throughout the end-to-end labeling process, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About You

Experience/Qualifications:

• In-depth working knowledge of labeling, guidance, and agency regulatory action history is required
• 5 years pharmaceutical/biotechnology industry experience with a minimum of 3 years’ experience in Labeling
• Master’s degree (Life Sciences or Health Sciences or related field preferred), OR MD, OR PharmD

Skills:

• Excellent written and verbal communication skills
• Demonstrated ability to solve problems and proactivity
• Ability to work with multifunctional and culturally diverse teams
• Organizational skills, ability to manage multiple projects at short notice.
• Excellent inter-personal skills
• Work with minimal oversight
• Fluent business English

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

This position is for a current vacant role that we are actively hiring for.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch ‘One day at Sanofi’ and check out our Diversity Equity and Inclusion initiatives at sanofi.com