Director Core Labeling Strategy

1100 Mylan Pharmaceuticals Inc.; Washington (District of Columbia); On-site; USD 112,000 - 236,000; Full time

Job summary

Viatris is seeking a Director Core Labelling Strategy to lead global labeling governance for a broad portfolio. The role requires strategic leadership across development and lifecycle management with a focus on CCDS, USPI, and EU SmPCs.

You will chair the Product Labeling Teams, coordinate with Global Regulatory, PSRM, and Clinical Safety, and ensure regulatory acceptance across major markets while guiding cross-functional teams through complex labeling challenges.

Qualifications

• Minimum of a Bachelor's degree in Science, Medicine or Pharmacy with 10 years of regulatory experience.
• Master's Degree, PharmD, or PhD preferred; combination considered.
• Experience in global labelling strategy and development including CCDS, USPI, and EU SmPCs.

Responsibilities

• Provide regulatory labelling leadership, governance, and expertise for global labeling across products.
• Lead preparation, review, and approval of CCDS, USPI, and EU SmPCs; drive labeling strategy with Global Regulatory.
• Chairs cross-functional Product Labeling Teams (PLT) and collaborates with Global Medical, PSRM, and Regulatory teams.
• Interacts with senior management and external groups to ensure regulatory alignment and strategic labeling decisions.

Skills

Regulatory labeling

Global labeling strategy

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Science/Medicine/Pharmacy

Master's/PharmD/PhD preferred

Job description

Mylan Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Every day, we rise to the challenge to make a difference and here’s how the Director Core Labeling Strategy role will make an impact:

Key responsibilities for this role include:

Provide regulatory labelling leadership, governance, and expertise to Viatris products such that the Product Information texts (labelling) of existing and new products are successfully developed, maintained and implemented globally in compliance with applicable regulatory requirements. In this role the individual will have responsibility for the creation, development, and maintenance of compliant Core Labelling documents including Company Core Data Sheets (CCDS) and associated patient information, as well as oversight of Global Ad Promo and Medical Marketing review and approval, in alignment with Viatris principles and procedures. The role also contributes to strategic labelling development across the product lifecycle, including supporting early development programmes through the development of Target Product Labelling (TPL), competitive labelling analyses and regulatory precedent assessments to support global regulatory strategy and major submissions, including US Prescribing Information (USPI).

Accountable for management of the global labelling process and labelling development across the assigned portfolio. 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 US Prescribing Information (USPI)) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies. Drives labelling strategy in partnership with Global Regulatory in line with the overall regulatory strategy by providing labelling expertise (labelling regulations, internal processes, competitive labelling analysis and impact assessment 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. Leads development and maintenance of Target Product Labelling (TPL) to guide clinical development strategy, regulatory positioning and cross-functional alignment, particularly for innovative or development-stage assets. Ensures 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 and 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 across both development and lifecycle management activities. 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. Controls global Labelling compliance by reconciling labeling deviations with Company Core Position (e.g. CCDS and corresponding Patient Information) by assessing change requests for labeling documents, driving responses to Health Authorities and other requesting parties, and approving the final outcome. Chairs cross-functional Product Labeling Teams (PLT), including identifying and engaging and engaging ad hoc subject matter experts from relevant support functions as needed. Collaborates closely with Global Medical and Clinical Services and Global Product Safety and Risk Management (PSRM) – Safety Surveillance as well as Clinical Safety Team to ensure that all Product Information (PI) content is authored is scientifically accurate, validated, and aligned with safety and clinical requirements. Where agreement cannot be reached, initiates and manages escalation to the Global Labelling Committee (GLC) for review, decision-making, and implementation in accordance with the global labelling governance framework. Maintains strong awareness of competitor labels, evolving external labelling trends and agency requirements to inform labelling strategy and support product differentiation where appropriate. Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously and employs sound judgment in solving complex problems. Reviews and approves promotional materials with respect to CCDS and relevant codes of conduct according to company requirements and processes and counsels strategic review of competitor and existing Viatris labelling documents as necessary. Reviews, advises on and approves documents from Clinical Development, Medical Affairs, Pharmacovigilance and other scientific functions as appropriate, e.g. Investigator Brochure, documents, periodic reports (such as Clinical Study Protocols, Clinical Study Reports, PSURs, RMP, ACO), and Core Value Dossiers. Internally influences interpretation of emerging regulatory guidelines and proposed regulations impacting labelling strategy. Manages, leads, directs and supervises direct reports, including recruitment, coaching, performance management and development within the Labelling team. Contributes to the leadership of the Global Labelling Organization. Counsels project teams and participate in Regulatory team meetings, representing Labelling Strategy as appropriate. 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). Performs other labelling duties as assigned.

The minimum qualifications for this role are:

Minimum of a Bachelor's degree (or equivalent) in Science, Medicine or Pharmacy, or another related field with 10 years of regulatory experience, including significant experience in global labelling strategy and development. Preferred candidate will have a Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy. However, a combination of experience and/or education will be taken into consideration. Demonstrated experience in labelling development, including development and maintenance of global core labelling (e.g. CCDS) and major market labelling such as US Prescribing Information (USPI) and EU SmPCs. Demonstrated experience developing first-cycle or initial submission labelling for innovative products in major regulatory markets (e.g., NDA/BLA or MAA submissions) is strongly preferred. Experience in strategic labelling activities such as Target Product Labelling (TPL) development, competitive label benchmarking, and regulatory submission support is considered an advantage. Regulatory experience including in-depth global labelling knowledge across development and lifecycle management. Understand Product Labeling Team (PLT) and Global Labelling Committee (GLC) governance processes and EU and US regulatory labelling requirements, including development and maintenance of EU and US Prescribing Information (USPI) and Company Core Data Sheets (CCDS). Familiarity with competitive labelling assessments and experience in Target Product Labelling (TPL) development to support regulatory strategy. Experience in developing first-submission labelling for innovative products in major regulatory markets (e.g., US, EU). Prior leadership experience with direct reports and demonstrated ability to lead and develop others. Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization. Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems. 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. 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.

Exact compensation may vary based on items such as skills, experience and location. The salary range for this position is: $ 112,000 - $236,000. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.