Regulatory Strategist Senior Manager

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.

Key responsibilities 

• Developing or contributing to Global/Regional regulatory strategies and implementation plans developed for assigned projects/products., Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, and minimize resource demands while optimizing overall project delivery time and probability of success and facilitating post-filing activities.
• Partnering with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, Supply, etc.) to ensure required regulatory contributions (briefing documents, Global Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) meet business needs and are provided to the project teams, in accordance with agreed time, cost and quality standards.
• Developing and maintaining constructive working relationships with Health Authority contacts.
• Delivering the project/product regulatory goals and aligning the regulatory strategy with global/regional business needs.
• Ensuring regulatory plans are monitored, progress/variance is communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) is mitigated.
• 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 supporting the business are championed and communicated.
• Working closely with other Regulatory Strategists and CMC Team within and across clusters/TAs and sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
• Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
• Engaging in appropriate activities in order to influence the regulatory environment through Health Authority contacts, Country Office partners and trade associations as appropriate.

Qualifications and Experience

• B.S. Scientific Degree required.  An advanced Scientific Degree (Ph.D., PharmD., M.D., M.Sc.) and/or a business qualification (DMSc, MBA) may be an advantage but is not essential.
• 5 years of US Regulatory experience required. 3 years Global regulatory experience preferred.
• 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, Safety, Medical and other partner lines to achieve objectives.
• Proven ability to successfully communicate and negotiate with major Health Authority(ies), including leading and participating in such interactions.
• Knowledge of assigned therapeutic areas/disease areas is preferred.
• 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.
  Ability to work independently with minimum supervision.
• Sedentary - Minimal handling of light materials and tools, lifting up to 10 lbs. May involve walking or standing for brief periods of time.
• Proficiency in speaking, comprehending, reading and writing English is required.