Labeling Strategist

BioTalent Canada; Toronto; On-site; CAD 110,000 - 140,000; Full time

Benefits offered by this job

Healthcare benefits

Global opportunities

Inclusive workplace

Job summary

Sanofi is seeking a regulatory labeling expert to lead cross-functional labeling efforts for EU/US workflows and regulatory submissions. You will craft labeling strategies, coordinate reviews, and ensure alignment with health authorities globally.

The role requires strong knowledge of CCDS, EU/US guidance and excellent communication across regions and functions.

Qualifications

• 3+ years in pharmaceutical regulatory affairs or labeling.
• Knowledge of CCDS, EU and US labeling guidance/regulations.
• Strong written and verbal communication skills, with networking ability.

Responsibilities

• Define and lead labeling strategy for regulatory submissions and MAAs.
• Coordinate labeling reviews across the end-to-end process with agencies.
• Support global labeling strategy and prepare labeling components for dossiers.

Skills

Regulatory labeling

Global regulatory

Cross-functional leadership

Healthcare regulations

Education

Bachelor’s degree in Life Sciences

Medical or pharmacy degree

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.

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.

Main responsibilities:

• Define and Lead Labeling strategy to create or update corporate labeling documents (CCDS, US, EU, WHO) and corresponding patient leaflet for development projects and LCM/marketed products (including TPL for new indications) within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations, obtain company and/or agency approval.
• Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for development, marketed and LCM products (including complex updates, line extensions, new indications).
• Support cross-functional teams as a labeling expert (within GRAL, GRT and GRA) and contribute to the definition of global regulatory strategies and to the preparation of labeling components of submission dossiers or responses to Health Authorities
• Chairs multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governance Committee for internal approval of proposed labeling.
• Be a member of Response Teams within procedures for EU and US Procedures including complex issues (e.g. European Arbitration/referrals, or work sharing, PRAC questions (signal detection, Labeling negotiations, Urgent Safety restrictions…) for the maintenance and compliance of existing Marketing Authorizations
• Anticipates any hurdles in implementation and acts to minimize them, informing management as needed
• Coordinate, create and clearly present labeling proposals to Senior Executive Management via Labeling Review Committee
• Assess relevant study reports, pharmacovigilance data (post-marketing) and any other scientific reports required for support labeling proposals.
• Perform labeling competitive/comparator analysis to provide expert- level insights
• Meet established submission timelines and quality standard for labeling deliverables.
• Provide training/mentoring to students, VIEs, or apprentices on CCDS, EU, & US guidance and regulations and strategy to implement into labeling text
• Lead Transversal or process improvement workstreams/projects

About you

Experience:

• Knowledge of regulatory and labeling requirements in major markets pertaining to marketing authorization filings for new products or updates to existing marketed products. Knowledge of the dynamics of Labeling Team purpose and objectives.
• Strong knowledge of labeling requirements for drugs (CCDS, EU, & US guidance and regulations, drug-device combinations); organizational and networking skills; and ability to coordinate discussions across all levels of the company to reach resolution on labeling topics.
• Knowledge of US and EU regulations and general international regulatory environment,
• Ability to read and interpret HA regulations and guidance, and relevant company SOPs.
• Proven ability to lead Labeling strategy connecting to regulatory strategy
• Ability to lead matrix teams, manage up, negotiate, and build consensus on complex topics.
• Strong ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC…), provide labeling strategy proposal, negotiate, resolve conflict and build consensus.
• Support local countries as global labeling SME (ie during labeling negotiation, HA discussion, etc…)
• Must be able to construct a Company Response (MAH response) for health authority (EU/US) questions related to labeling.
• Minimum of 3+ years in pharmaceutical industry preferably regulatory affairs or a minimum of 2 years of labeling experience
• Excellent written and verbal communication skills, networking skills.
• Situational awareness and leadership skills, problem solving skills.
• Organizational skills, ability to manage multiple projects at short notice.
• Must be able to work with all levels of associates and direct management within the Company (domestic/international) and demonstrate good communication, interpersonal and organizational skills.
• Highly detail oriented, strong analytical and organization skills, project management skills, self-starter, leadership skills, critical thinking required, strong ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.

Technical skills:

Ability build/learn scientific knowledge (e.g. statistics, disease area) to improve agility and work across therapeutic areas. Enhanced ability to search for public data on labeling elements and regulatory strategy (enabling digital capabilities)

Education:

Education: Physician, Pharmacist, Veterinarian, Academic, Research or bachelor’s degree in Life Sciences Degree.

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 new vacant role that is now open for applications.

AI Usage

“Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information toidentifypatterns, improve services, or support decision-making. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concernregardingyour personal information. You can also contact Canada’s Privacy Officer via Sanofi’s datasubject request portal, can also be used to request access or correction of your personal information and file a complaint.

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.

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.