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.
Provides oversight for team and assigned products, and provides strategic guidance and training on projects (including review and validation of Labeling proposals as needed), informing management as necessary
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 team on CCDS, EU, & US guidance and regulations and strategy to implement into labeling text
Lead and support transversal or process improvement workstreams/projects
Execute training plans, assessing competency of team members, and closing individual training gaps through targeted development.
Conduct performance management—goal setting, feedback, and coaching—for a team.
Assign and balance product responsibility across a team based on capacity and skill level.
Manage resource planning and coverage across vacations, turnover, sick leave, and peak workloads without disrupting deliverables.
Ensures coverage for products/projects within the group, identifying possible gaps, resource constraints, and implement solutions to present to management
Forecast capacity against portfolio demand and reallocate work when gaps emerge.
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 provide training/mentoring to junior Labeling team members on CCDS, EU, & US guidance and regulations and strategy to implement into labelling text
Ability to read and interpret HA regulations and guidance, and relevant company SOPs.
Proven ability to lead Labeling strategy and guide team of labeling strategists to connect to regulatory strategy
Ability to lead matrix teams, manage up, negotiate, and build consensus on complex topics.
Ability to work autonomously for most topics, requesting feedback on high complexity topics while providing oversight to direct reports.
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.
Knowledge of labeling end-to-end processes and the interfaces between Regulatory, Medical Affairs, Pharmacovigilance, Quality,
Defined experience requirement: 10+ years of relevant experience.
Additionally requires a minimum of 3 years of people management experience for individuals in the managerial track.
Experience executing training plans, assessing competency, and closing individual training gaps through targeted development.
Experience conducting performance management—goal setting, feedback, and coaching—for a team.
Demonstrated ability to assign and balance product responsibility across a team based on capacity and skill level.
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)
Strong ability to manage projects and people, documenting Progress and outcomes on responsible portfolio of products and people
Familiarity with labeling and document management systems (e.g., Veeva Vault, EDMS, RIM systems, text verification/QC tools).
Education: Physician, Pharmacist, Veterinarian or bachelor’s degree in Life Sciences Degree, advanced degree preferred.
Languages: Fluent business English.
