Viatris Inc.

Director, Regulatory Strategist

Viatris Inc. • $112K — $236K *
Washington, DC 20011In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • B.S. in a scientific field; advanced degree preferred (Ph.D., Pharm.D., M.D., M.Sc., or business qualification).
  • 8 years of Regulatory experience in US, EU, and EM; Global experience preferred.
  • Extensive understanding of the regulatory landscape to shape strategies.
  • Experience managing complex regulatory issues and multiple products across their lifecycle.
  • Strong negotiation and communication skills with Health Authorities.
  • Ability to collaborate with cross-functional teams effectively.
  • Regulatory Affairs Professional Certification is a plus.

Responsibilities

  • Develop and implement regulatory strategies for complex projects and products.
  • Collaborate with cross-functional teams to ensure timely regulatory contributions.
  • Provide regulatory input for clinical development and risk assessments.
  • Contribute to the Product Labelling Team for labeling strategies and updates.
  • Monitor regulatory plans, communicating progress to senior leadership.
  • Develop high-quality submission packages, ensuring all regulatory commitments are met.
  • Maintain relationships with Health Authority contacts and participate in agency meetings.

Benefits

  • Hybrid work model with office presence required two days a week.
  • Inclusive work environment that values diverse perspectives and skills.
  • Competitive benefits package to support employee wellbeing.
Full Job Description
Every day, we rise to the challenge to make a difference and heres how the Director, Regulatory Strategist role will make an impact:
  • Developing Global/Regional regulatory strategies and implementation plans for complex projects/products including novel, product enhancement and post approval products; Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, while optimizing overall project delivery time and probability of a successful outcome.
  • Partnering with project teams and other stakeholders (e.g. Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal) to ensure required regulatory contributions (briefing documents, Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) meet business needs and quality standards and are provided in accordance with agreed timelines.
  • Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development.
  • Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS and provide strategic input to the development and maintenance of labels as appropriate.
  • Ensuring regulatory plans are monitored, progress is communicated to Senior leadership and any risks (from emerging technical data, changing internal objectives or external impacts) are clearly communicated and mitigated where possible.
  • Developing fit-for-purpose submission packages in collaboration with partner lines. Ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining and maintaining Marketing Authorizations. Author sections of the dossiers, as applicable.
  • Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions are championed and executed on time and to the required quality standards.
  • Developing and maintaining constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate.
  • Supporting regulatory Due Diligence activities for business development opportunities.
  • Working closely with other Regulatory team members to develop and ensure adherence to processes, systems, working practices, shared learnings and quality standards.
  • Implementing systems, processes and procedures relating to regulatory productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
  • Enhanced understanding of current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, Country Office partners and trade associations.
  • Ensuring business compliance and implementation of and adherence to regulatory standards.
The minimum qualifications for this role are:
  • B.S. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) preferred.
  • Minimum 8 years of US,EU,EM Regulatory experience required. Minimum 5 years of Global Regulatory experience preferred . However, a combination of experience and/or education will be taken into consideration.
  • Relevant Global and/or Regional regulatory experience.
  • Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation.
  • Proven experience in managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management including ability to manage complex regulatory issues. Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable.
  • Proven ability to deliver to time, cost, and quality standards.
  • Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical, other partner lines and senior stakeholders to achieve objectives.
  • Proven track record of success in negotiating with major Health Authority(ies), including leading such interactions.
  • Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
  • Proven ability to deliver in a highly matrixed organization.
  • Strong written and verbal communication skills.
  • Desirable experience would include a strong track record of demonstrating extensive depth and breadth of regulatory strategy, enabling a leadership role to be assumed which requires minimal supervision.
  • Regulatory Affairs Professional Certification preferred.
  • Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel may be required. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements.
  • This is a hybrid role-required to be the DC office 2 days per week.
  • Proficiency in speaking, comprehending, reading and writing English is required.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000.00 - $236,000.00 USD. 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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