Team Lead GRA Labelling Strategist

Overview

Lead the labeling strategy for development and marketed products, coordinating corporate labeling documents and patient leaflets within regulatory submissions and leading a team of labeling strategists.

What you'll do

• Define and lead labeling strategy to create or update corporate labeling documents (CCDS, US, EU, WHO) and corresponding patient leaflets for development projects and LCM/marketed products, including TPL for new indications.
• Coordinate labeling review and approval across the end-to-end labeling process, including preparation of submission components, labeling negotiations with agencies, and release of labeling for use.
• Support cross-functional teams as a labeling expert within GRAL, GRT and GRA, and contribute to global regulatory strategies and submission dossiers or Health Authority responses.
• Chair multi-disciplinary labeling working groups, present labeling proposals, build consensus, and present proposals to the Labeling Governance Committee and Labeling Review Committee.
• Provide oversight for the team and assigned products, including strategic guidance and review and validation of labeling proposals.
• Be a member of Response Teams for EU and US procedures, including complex issues such as European arbitration/referrals, work sharing, PRAC questions, labeling negotiations and urgent safety restrictions.
• Anticipate implementation hurdles and act to minimize them, informing management as needed.
• Assess relevant study reports, pharmacovigilance data and other scientific reports to support labeling proposals, and perform labeling competitive/comparator analysis.
• Meet established submission timelines and quality standards for labeling deliverables.
• Provide training and mentoring to the team on CCDS, EU and US guidance, regulations and strategy to implement into labeling text.
• Lead and support transversal or process improvement workstreams and projects.
• Execute training plans, assess team competency and close individual training gaps.
• Conduct performance management, including goal setting, feedback and coaching for the team.
• Assign and balance product responsibility across the team based on capacity and skill level.
• Manage resource planning and coverage across vacations, turnover, sick leave and peak workloads, and forecast capacity against portfolio demand.

What you'll need

• 10+ years of relevant experience.
• Minimum 3 years of people management experience for the managerial track.
• Knowledge of regulatory and labeling requirements in major markets for marketing authorization filings for new products or updates to existing marketed products.
• Strong knowledge of drug labeling requirements (CCDS, EU and US guidance and regulations, drug-device combinations).
• Knowledge of US and EU regulations and the general international regulatory environment.
• Ability to read and interpret Health Authority regulations, guidance and relevant company SOPs.
• Proven ability to lead labeling strategy and guide a team of labeling strategists in 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) and resolve conflict.
• Ability to support local countries as global labeling SME during labeling negotiations and Health Authority discussions.
• Ability to construct a Company Response (MAH response) for EU and US Health Authority labeling questions.
• Knowledge of labeling end-to-end processes and interfaces between Regulatory, Medical Affairs, Pharmacovigilance and Quality.
• Experience executing training plans, assessing competency and closing individual training gaps.
• Experience conducting performance management, including goal setting, feedback and coaching.
• Demonstrated ability to assign and balance product responsibility across a team based on capacity and skill level.
• Excellent written and verbal communication, networking, situational awareness, leadership and problem-solving skills.
• Ability to manage multiple projects at short notice and work with all levels of associates and management, domestic and international.
• Highly detail-oriented with strong analytical, organizational, project management and critical thinking skills.
• Ability to build scientific knowledge (e.g. statistics, disease area) and search public data on labeling elements and regulatory strategy.
• 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.
• Fluent business English.

Nice to have

• Advanced degree.

Details

• Location: Hyderabad, India.
• Hybrid work model.