Position title: Labeling Strategist

Department: Global Labeling Strategy- R&RBD

Location: Toronto, ON

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

Soft skills:

• 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.

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 to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. 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 concern regarding your personal information. You can also contact Canada's Privacy Officer via Sanofi's data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.

North America Applicants Only

The salary range for this position is:
127,000.00 - 177,000.00 (Includes target bonus)
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINKOR (US) LINK.

La fourchette salariale pour ce poste est la suivante:
127,000.00 - 177,000.00 (Comprend le bonus cible)
La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien