Recruit, hire, and onboard team members, including defining role competencies and evaluating candidates.
Build and executing 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.
Develop contingency/backup coverage models so no product goes unowned.
Track and report status across a large portfolio using dashboards, trackers, or portfolio management tools.
Establishing and monitoring KPIs/metrics for quality and timeliness (e.g., on-time submission rate, errors/deviation rate, cycle time).
Utilize project/portfolio management methods for competing deadlines across 250 products.
Define and Lead Labeling strategists to create or update corporate labeling documents (CCDS, US, EU, WHO) and corresponding patient leaflet for development projects (including TPL) and complex LCM/marketed products within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations, obtain company and/or agency approval.
Coordination and accountability of the team through the 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 (including early development TPL creation), marketed and LCM products (including complex updates and line extensions) and due diligence opportunities.
Ensure team’s ability to support cross-functional teams as a labeling expert (within and outside 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
Ensure team’s ability to chair 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 and guidance for team and assigned products and provide strategic guidance and training as needed for complex labeling projects (including review and validation of labelling proposals as needed), informing management as necessary.
Extended GRA Labelling Leadership team representative
Be a member of Response Teams within procedures for EU and US Procedures for highly 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
Identifies risks and anticipates any hurdles in implementation for the product portfolio and acts to minimize them, informing management as needed.
Ensure coordination, creation and clear presentation of labeling proposals to Senior Executive Management via Labeling Review Committee
Ability to guide and ensure assessment of relevant study reports, pharmacovigilance data (post-marketing) and any other scientific reports required for support labeling proposals for team members.
Direct the performance of complex labeling competitive/comparator analysis to provide expert-level insights
Meet established submission timelines and quality standard for labeling deliverables.
Provide training/mentoring to junior labeling team members on CCDS, EU, & US guidance and regulations and strategy to implement into labeling text
Lead complex transversal or process improvement workstreams across a wide range of labeling and GRA topics
Ability to interpret and apply health authority requirements (FDA, EMA, and other relevant agencies).
Experience: Knowledge of regulatory and labeling requirements in major markets pertaining to marketing authorization filings for new products (including early development and TPL) or updates to existing marketed products. Knowledge of and the dynamics of Labeling Team purpose and objectives.
Extensive 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.
Proven ability to lead labeling strategy and guide team of labeling strategist to connect to regulatory strategy
Ability to lead matrix teams, manage up, negotiate and build consensus on high complex topics.
Very 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.
Deep knowledge of labeling end-to-end processes and the interfaces between Regulatory, Medical Affairs, Pharmacovigilance, Quality, and Supply Chain Defined experience requirement: 15+ years of relevant Regulatory and labeling experience.
Additionally requires a minimum of 5+ years of people management (ideally leading a team of 10 or more), team management and project management experience Proven ability to manage stakeholders at multiple levels, including site leadership and the functional department.
Proven ability to recruit, hire, and onboard staff, including defining role competencies and evaluating candidates.
Experience building and 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.
Experience managing resource planning and coverage across vacations, turnover, sick leave, and peak workloads without disrupting deliverables.
Ability to forecast capacity against portfolio demand and reallocate work when gaps emerge.
Experience developing contingency/backup coverage models so no product goes unowned.
Experience establishing and monitoring KPIs/metrics for quality and timeliness (e.g., on-time submission rate, error/deviation rate, cycle time).
Working knowledge of project/portfolio management methods to manage competing deadlines across large product portfolio.
Soft skills: Excellent written and verbal communication skills, networking skills.
Situational awareness and strong leadership skills, problem solving skills.
Organizational skills, ability to manage team members working on multiple projects, including those 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, very strong ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
Support global discussions and local countries as global labeling SME (ie during labeling negotiation, HA discussion, etc…)
Must be able to construct and guide creation of a Company Response (MAH response) for health authority (EU/US) questions related to labeling.
Technical skills: Ability build/learn scientific knowledge (e.g. statistics, disease area) to improve agility and work across therapeutic areas. Strong ability to manage/lead 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).Strong ability to search for public data on labeling elements and regulatory strategy (enabling digital capabilities). Demonstrated ability to track and report status across a large portfolio using dashboards, trackers, or portfolio management tools.
Education: Physician, Pharmacist, Veterinarian or Life Sciences Degree, advanced degree preferred.
Languages: Fluent business English.
