Senior Director - Brands Regulatory Affairs

Mylan Inc.

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. 

Every day, we rise to the challenge to make a difference and here’s how this role will make an impact:

Key responsibilities for this role include:

• To provide and ensure globally aligned regulatory strategies are in place and implemented for all products in the team’s portfolio, including, development of strategies for growth opportunities and responding to Regulatory agency queries, in order to meet Business priorities. This includes accountability for providing strategic regulatory guidance for projects/products both as an individual contributor and/or through support of regulatory strategists within the team.

• Ensure an aligned global/regional regulatory position is developed for all key issues for assigned projects/products and that these are appropriately communicated.

• Collaborate across Global Regulatory Affairs (GRA) to provide global regulatory strategic guidance to stakeholders across the organization.  Where required, work with the policy team to contribute to the development of evolving regulatory guidelines and regulation through Health Authority engagement, collaboration with local country regulatory colleagues and trade associations.  Ensure the impact of new requirements are understood and appropriately managed within the team. Contribute to the establishment of strong partnerships with project teams and other stakeholders (e.g. Clinical, PSRM, Medical, GCMC, Quality, R&D, Commercial, Legal) to input to the clinical and overall development programs and ensure optimal regulatory contributions to project deliverables.  This includes regulatory submission documentation (Briefing documents, MAA/NDAs/INDs), clinical protocol development, Regulatory Strategy Documents (RSDs), PTRS, Target Product Profile (TPP) and Target Product Label (TPL) development, CCDS and national labels, RMPs, Benefit/Risk evaluations.  All contributions should meet business needs and quality standards and be provided in accordance with agreed timelines.

• Ensure regulatory plans for the team are closely monitored, progress is communicated in a timely manner and strategies are developed to mitigate any risks from emerging technical data, changing internal objectives or external impacts.

• Lead regulatory Due Diligence activities for business development opportunities.

• Directly supervise team of Regulatory Strategists, with responsibility for performance management and support for professional development of staff through talent management and career development opportunities. Provide clear leadership and manage workload, ensuring effective prioritization and utilization of resources across the team.

• Ensure implementation of consistent quality standards and contribute to the development of appropriate processes, systems, working practices and shared learnings to ensure full compliance with all regulations and corporate policies in collaboration with the regional leaders and groups. Contribute to or lead Global/US/EU/EM change management, continuous improvement and regulatory remediation project activities.

• Develop and strengthen relationships with FDA, EMA and national regulatory agencies, where appropriate. Support Regional Regulatory Affairs in the development and maintenance of local regulatory agency relationships.

The minimum qualifications for this role are:

• Minimum of a Bachelor's degree (or equivalent) required.  A Doctorate degree (or equivalent) is preferred. 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. However, a combination of experience and/or education will be taken into consideration

• 5 years of Global Regulatory experience is required

• 10 years of US/EU/EM region specific Regulatory experience is required

• 2 years of people management is preferred

• Relevant Global and/or Regional regulatory experience  

• In-depth knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation.

• Experience in managing global and/or 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.

• Strong leadership experience with an ability to influence within regulatory and across business functions.

• Demonstrated commitment to development of others.

• Proven ability to successfully communicate and negotiate with major Health Authority(ies). Strategy development and leadership of interactions and meetings with Health Authorities

• 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 

• Regulatory Affairs Professional Certification is preferred

• Direct supervision of 6-12 professional level employees

• Periodic travel is required

• 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 $151,000 - $314,000.

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.

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