Director, Global Regulatory Strategist

Generics [U.K.] Ltd.

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 1 billion 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.
 

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 

Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies for complex products/projects, integrating inputs from regulatory team and cross functional partners to build globally aligned regional regulatory strategies. Strategies should be in alignment with business objectives and key stakeholders/partner lines.

Manage the preparation and submission of correspondence and applications to regulatory agencies. Organize, lead or participate in meetings with regulatory agencies, as appropriate.  Ensure quality expectations are met for all submissions and Health Authority interactions. 

Direct and/or indirect liaison with Health Authorities (in conjunction with Regulatory Country partners to facilitate the prompt review and approval of applications, supplements/variations, and commitments).

Lead global Regulatory Teams for assigned projects/products.

Every day, we rise to the challenge to make a difference and the Director, Global Regulatory Strategist role will make an impact through the following responsibilities:

·Developing Global/Regional regulatory strategies and implementation plans for complex projects/products including innovative, 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 aligned 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 contribute to the development and maintenance of local labels as appropriate.

·Ensuring regulatory plans are monitored, progress is communicated to Senior Management 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.

·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 Authorities enhancing Viatris reputation through all communications.

• Working closely with other Regulatory team members to ensure consistent and appropriate 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.

• Supporting regulatory Due Diligence activities for business development opportunities. 

• Acting as regulatory representative in projects with partnership or alliance partners

• Mentorship of junior colleagues.

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:

• B.S. Scientific Degree required.  An advanced Scientific Degree (Ph.D., PharmD., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential

• Regulatory Affairs educational specialization may be an advantage but is not essential

• Relevant Global and/or Regional regulatory experience  

• Extensive  knowledge of the global regulatory environment and how this impacts regulatory strategy development and implementation.

• Proven Experience in managing global and regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management with 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, R&D, PSRM, Clinical, Medical and other partner lines to achieve objectives.

• Ability to work independently with appropriate escalation.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 effectively deliver in a highly matrixed organization 

• Strong written and verbal communication skills 

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:

• Top Employer Accreditation, demonstrating that we provide excellent people policies and practices

• Competitive compensation package

• Focus on career progression with growth and development opportunities

• Emphasis on Health & Wellness programmes

• 100% paid medical insurance and Employee Assistance Programme

• Life cover

• Excellent employer-matched pension scheme with Viatris contributing up to 11%

• 2 paid volunteer days per year

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. 

 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  

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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.

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