Senior Director Global CMC Strategy

Generics [U.K.] Ltd.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
 

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

The Senior Director Global CMC Strategy is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise. The Senior Director will be responsible for providing regulatory guidance and leadership for eyecare products, expediting the preparation and review of regulatory submissions in support of Viatris’ eyecare portfolio.

Every day, we rise to the challenge to make a difference and here’s how the Senior Director Global CMC Strategy role will make an impact:

• To guide, develop and execute regional and global regulatory CMC strategies specific to assigned Viatris’s eyecare portfolio to meet the needs within the regions. Facilitate timely regulatory submission and approval by managing adherence to the Regulatory Affairs schedule for new applications and deficiency responses.

• Provide strategic recommendations and direction within Global Regulatory Affairs and with cross-functional technical teams to reduce regulatory risks and minimize delays associated with submission and approval of products. Ensure an aligned regulatory position is reached and communicate proposed risks and risk mitigation strategies to Senior Leadership.

• Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.

• Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author CMC sections of the dossiers from technical documentation, as applicable.

• Ensures lifecycle management and maintenance activities, including change controls, are assessed and executed effectively and efficiently.

• Developing and maintaining constructive working relationships with Health Authority contacts.  Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions.

• Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards.

• 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, partners and trade associations.

• Supporting regulatory Due Diligence activities for business development opportunities.

• Provide input to and adhere to departmental budget.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Minimum of a Bachelor's degree (or equivalent). An advanced Scientific Degree (Ph.D., Pharm. D., M.Sc.) is preferred.

• Extensive pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and pharmaceutical regulatory experience required. A combination of experience and/or education will be taken into consideration.

• Prior CMC experience with eyecare products is required. Knowledge of medical devices and combination products is an advantage.

• Prior experience managing projects and matrixed teams and/or serving as a people manager.

• Global Regulatory Affairs CMC strategy, with hand-on CMC authoring experience (initial registrations or post-approval variations)

• High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects.

• Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle.

• Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.

• Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.

• Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.

• Demonstrated strategic thinking and ability to integrate strategies into actionable plans.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at Viatris

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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offercompetitivesalaries, benefitsandan 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.

#LI-DNI