Director Regulatory Strategist Jobs

3849 Viatris Specialty LLC

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 the role will make an impact:

Key responsibilities for this role include:

• Delivering the project/product regulatory goals and aligning the regulatory strategy with global/regional business needs.
• 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, communicated and executed.
• Developing fit-for-purpose submission packages in collaboration with partner lines
• Developing and maintaining constructive working relationships with Health Authority contacts.
• 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.
• Developing Global/Regional regulatory strategies and implementation plans developed for complex 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.
• 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.
• Ensuring business compliance and implementation of and adherence to regulatory standards.
• 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) are mitigated

The minimum qualifications for this role are:

• Proficiency in speaking, comprehending, reading and writing English is required
• Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical, other partner lines and senior stakeholders to achieve objectives
• Proven ability to deliver to time, cost, and quality standards
• Proven track record of success in negotiating with major Health Authority(ies), including leading such interactions
• 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.
• Bachelor’s degree required in a Scientific specialization required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) preferred.
• Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
• 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.
• Knowledge of assigned therapeutic areas/disease areas is preferred
• Proven ability to deliver in a highly matrixed organization.
• 8 years of US Regulatory experience required. 5 years of Global Regulatory experience preferred. However, a combination of experience and/or education will be taken into consideration.
• Regulatory Affairs Professional Certification preferred
• Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation

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.