Viatris
Website:
viatris.com
Job details:
POSITION PURPOSE
Provide regulatory labelling proficiency, governance, and expertise to Viatris products such that the, Core Labelling Strategy and Product Information texts (labelling) of existing and new products are successfully maintained globally.
In this role the individual will have responsibility for the creation, development, and maintenance of compliant Core Labelling documents including Global Ad Promo and Medical Marketing review and approval, in alignment with Viatris principles and procedures.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Accountable for management of the labelling process and labelling development.
- Leads preparation, review and approval of global labelling documentation (e.g. CCDS, Core Patient Information) as well as territorial labelling documentation (e.g. Common EU SmPC’s and USPI’s) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies.
- Leads labelling strategy in partnership with Global Regulatory in line with the overall regulatory Strategy by providing labelling expertise (labelling regulations, internal processes, and impact analysis of competitor profiles) for CCDS, USPI (including Abbreviated New Drugs Applications, New Drug Applications and Biologics License Applications) and group managed EU SmPC’s (Centralized / Mutual Recognition / Decentralized Procedures) as well as abbreviated PIs thereof.
- Establishes close partnership of labelling leads with project leads and the regulatory matrix to ensure effective, strategic, and proactive labelling development. Interfaces directly with senior management, functional experts, on business strategy and labelling content.
- Works closely with the aligned Regulatory Strategist and any other stakeholder teams as needed to lead all labelling aspects for the defined portfolio.
- Leads labelling updates and development, critically evaluating the data and principles upon which labelling statements are based to ensure clinical relevance and regulatory acceptance across the portfolio.
- Working with Global Product Safety and Risk Management – Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Global Labelling Committee (GLC) for endorsement of recommendations.
- Commercially astute, with a strong understanding of competitor labels and evolving external labelling trends and agency requirements
- Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously and employs sound judgment in solving complex problems
- Internally, influences key proposed guidelines and regulations to shape external environment
- May be active in external facing activities and is effective at representing Viatris in various industry groups (such as e.g., DIA, Navitas, trade associations) or at EMA (European Medicines Agency)- or FDA-sponsored events (e.g., Workshops, Ad Coms)
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