Viatris Inc.

Senior Manager, Core Labeling Strategy

Viatris Inc. • $95K — $193K *
Washington, DC 20011In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science, Medicine, Pharmacy, or related field with 7-10 years of significant labelling experience.
  • Proven experience in developing and maintaining global core labelling (e.g. CCDS) and market-specific labelling (e.g. USPI, EU SmPC).
  • Preferred experience with regulatory submissions (e.g. NDA/BLA/MAA).
  • Experience in Target Product Labelling development and competitive labelling analysis is beneficial.
  • Strong interpersonal and communication skills, with a demonstrated ability to influence in a cross-functional team setting.
  • Ability to function autonomously and supervise staff, handling various management tasks.

Responsibilities

  • Manage and deliver labelling activities for assigned products and portfolios.
  • Lead the development and approval of global labelling documentation including TPL and CCDS.
  • Collaborate with global regulatory teams to align labelling strategy with business goals.
  • Contribute to Target Product Labelling development for regulatory positioning.
  • Establish partnerships with Regulatory, Medical, Safety, and Clinical teams to advance labelling development.
  • Evaluate data for labelling updates to ensure scientific accuracy and compliance.
  • Assess deviations from company core positions and respond to health authority queries.
  • Contribute to Product Labelling Teams and escalate key issues as necessary.
  • Maintain awareness of competitor labelling and regulatory trends to inform strategies.

Benefits

  • Competitive salaries and comprehensive benefits package.
  • Inclusive work environment that values diverse experiences and perspectives.
  • Opportunities for professional growth and development.
Full Job Description
Every day, we rise to the challenge to make a difference and heres how the Senior Manager, Core Labeling Strategy will make an impact:
  • Provide global regulatory labelling expertise and leadership to ensure Product Information (labelling) for both existing and new Viatris products is developed, maintained, and implemented in compliance with applicable regulatory requirements.
  • The role is responsible for the development and maintenance of Core Labelling (including CCDS and associated patient information) and supports Global Ad Promo and Medical/Commercial material review and approval in line with company principles and procedures.
  • Additionally, the role contributes to strategic labelling activities across the product lifecycle, including Target Product Labelling (TPL), competitive labelling analysis, and regulatory precedent assessment to support global regulatory strategy and major submissions (e.g. USPI, EU SmPC).
  • All activities are performed in accordance with applicable SOPs, regulatory requirements, and company policies.
Key responsibilities for this role include:
  • 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.
The minimum qualifications for this role are:
  • Bachelors 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.
  • 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
  • Position functions autonomously. The position may directly supervise employees. Carry out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000 - $193,000. 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.

About Viatris Inc.

They believe in healthcare as it should be empowering people worldwide to live healthier at every stage of life. Because of their unwavering belief that better access leads to better health, they leverage their best in class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

Viatris Inc. Careers

Join Viatris Inc., a global healthcare leader dedicated to empowering people to live healthier at every stage of life. We are currently expanding our team and offer a variety of job opportunities that promise not only professional growth but also a chance to make a meaningful impact. Work You’ll Do At Viatris Inc., you will collaborate with skilled professionals to drive innovation and deliver on our mission to provide access to high-quality medicine to the world's population. Our diverse team is our strength, and we thrive on creativity and the unique perspectives each member brings. Explore a range of positions—from research and development to marketing and sales—where you can leverage your skills to advance healthcare solutions. Our commitment to leadership in the industry is unwavering, and we equip our team with the tools they need to succeed. Viatris Inc. offers robust benefits designed to support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to retirement plans and wellness programs, we ensure our team is taken care of. Internship Programs Kickstart your career with Viatris Inc. through our internship programs. Gain invaluable industry experience, enhance your resume, and develop skills that will serve you throughout your career. Our internships provide a platform for learning and innovation, and a chance to work on real-world challenges in a supportive environment. Professional Growth and Development We believe in nurturing our employees' professional paths with extensive training and development programs that encourage continuous learning. Whether it’s leadership training, diversity initiatives, or career workshops, Viatris Inc. is committed to helping you grow at every level of your career. Join Our Team Are you ready to make a difference? Search for open positions that match your skills and interests. We are looking for passionate, curious, and solution-driven team players who are ready to take their career to the next level. Stay Connected Keep up to date with the latest at Viatris Inc. by joining our network. Follow us for career tips, company updates, and industry insights that can help you stay ahead in your professional journey. Connect with us to learn more about our culture and the exciting opportunities that await. Apply Now Discover the impact you could make with a career at Viatris Inc. Explore job opportunities, submit your resume, and prepare for an interview that could set you on a path to success. We are hiring now and looking forward to adding innovative and driven individuals to our team. Join Viatris Inc. today and be part of a global healthcare leader where your work matters and your career thrives.
Learn more about Viatris Inc.
Size
35,000 employees
Market Cap
$13 billion
Industry
Pharmaceuticals & Biotech
Net Income
-$669.9 million
5 Year Trend
+10.1%
Revenue
$11.9 billion
NASDAQ
VTRS
* Ladders Estimates

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