Experienced candidate at Manager/Senior Manager level to support the Core Labelling Strategy Team
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this position successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
· Accountable for management and delivery of labelling activities across assigned products/portfolio.
· Leads development, preparation, review, and approval of global labelling documentation (e.g. TPL, CCDS, Core Patient Information) and territorial labelling (e.g. EU SmPC, USPI) based on clinical and non-clinical data.
· Leads or supports development of labelling strategy in partnership with Global Regulatory, ensuring alignment with overall regulatory strategy and business objectives.
· Contributes to development and maintenance of Target Product Labelling (TPL) to support early development, regulatory positioning, and cross-functional alignment.
· Establishes strong cross-functional partnerships with Regulatory Strategists, Medical, Safety, and Clinical teams to ensure proactive and effective labelling development.
· Leads labelling updates and development, critically evaluating supporting data to ensure scientific accuracy, clinical relevance, and regulatory acceptability.
· Assesses and reconciles deviations from Company Core Position (e.g. CCDS) and supports responses to Health Authority requests.
· Chairs or actively contributes to Product Labelling Teams (PLTs), ensuring appropriate cross-functional input. Escalates key issues to the Global Labelling Committee (GLC) as required.
· Maintains strong awareness of competitor labelling, evolving regulatory requirements, and external trends to inform labelling strategy.
· Manages complex regulatory and scientific labelling issues, balancing compliance, business needs, and risk.
· Contributes to interpretation and application of emerging regulatory guidelines impacting labelling.
· May represent Viatris in external forums (e.g. industry groups, EMA/FDA workshops).
· Reviews and approves promotional and non-promotional materials for alignment with CCDS and applicable codes and requirements.
· Reviews and advises on key scientific and regulatory documents (e.g. IB, protocols, CSR, PSURs, RMPs) as appropriate.
· Provides labelling expertise in cross-functional and regulatory team discussions.
· Performs other labelling-related duties as assigned.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
KNOWLEDGE
· Regulatory experience with strong knowledge of global labelling across development and lifecycle management.
· Understanding of PLT and GLC governance frameworks and EU/US labelling requirements (SmPC, USPI, CCDS).
· Experience with TPL development and competitive labelling analysis.
· Experience supporting labelling for regulatory submissions in major markets (e.g. US, EU).
· Prior leadership experience or demonstrated ability to lead and influence others in a matrix environment.
SKILLS AND ABILITIES
Highly developed interpersonal, presentation and communication skills. Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations. The ability to influence effectively in a matrixed, cross-functional team environment
EDUCATION/EXPERIENCE
· Bachelor’s degree (or equivalent) in Science, Medicine, Pharmacy, or related field with typically 7–10 years of experience, including significant labelling experience.
· Demonstrated experience in development and maintenance of global core labelling (e.g. CCDS) and major market labelling (e.g. USPI, EU SmPC).
· Experience supporting regulatory submissions (e.g. NDA/BLA/MAA) preferred.
· Advanced degree (MSc, PharmD, PhD) is advantageous but not required.
· Experience in TPL development, competitive labelling benchmarking, and regulatory strategy support is an advantage
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 91140717
- Position Id: 9121200
- Posted 13 hours ago
