Director, Regulatory Strategist

Viatris; Dublin; On-site; EUR 140,000 - 190,000; Full time

Job summary

Viatris is seeking a Director, Global Regulatory Strategist to drive strategic regulatory direction for its originator and complex product portfolio. The role leads global/regional regulatory plans, interfaces with Health Authorities, and collaborates with cross-functional teams to ensure timely approvals and lifecycle management.

The ideal candidate has strong strategic and negotiation skills, experience in a matrixed global organization, and a track record of delivering regulatory milestones

Qualifications

• B.S. Scientific Degree is required.
• Advanced scientific degree and/or business qualification may be an advantage but not essential.
• Global/regional regulatory experience with ability to impact strategy.
• Experience managing global/regional regulatory and registration activities.
• Experience delivering across multiple products and lifecycle stages.
• Proven ability to collaborate with senior stakeholders to achieve objectives.
• Proven track record of negotiating with major Health Authority(ies).
• Strategic thinking and ability to translate strategy into action.

Responsibilities

• Develop global/regional regulatory strategies and plans for complex products.
• Lead regulatory sub-teams and coordinate cross-functional partners.
• Interact with Health Authorities and support submissions and variations.
• Support regulatory due diligence for business development opportunities.
• Monitor plans and communicate risks to Senior leadership.
• Contribute to label negotiations and TPL/CCDS updates.

Skills

Regulatory strategy

Cross-functional leadership

Strategic thinking

Regulatory negotiation

Global/regional regulatory

Project delivery

Education

B.S. Scientific Degree

Advanced scientific degree (Ph.D./Pharm.D./M.D./M.Sc.)

MBA or other business qualification

Job description

About the Company

McDermott Laboratories Limited 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. Every day, we rise to the challenge to make a difference, and here’s how the Director, Regulatory Strategist role will make an impact...

Role Overview

The Director, Global Regulatory Strategist is a senior level position, recognized as an expert for global regulatory strategy in support of Viatris’ innovative and established originator product portfolio. The purpose of this role is to: Provide strategic regulatory guidance using innovative regulatory approaches for assigned projects/products. Develop and implement Global regulatory strategies for complex products/projects, integrating inputs from regulatory team and cross functional partners. Strategies should be in alignment with business objectives and key stakeholders. 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 facilitate indirect communications with Health Authorities (in conjunction with Regulatory local/regional partners) to facilitate product development, prompt review and approval of applications, supplements/variations, and commitments. Lead global Regulatory Teams for assigned projects/products.

Key Responsibilities

• Global Regulatory Strategy Developing Global/Regional regulatory strategies and implementation plans for complex projects/products including novel, product enhancement, post approval and established 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.
• Leading the Global Regulatory sub- team and partnering with cross functional project teams as the Regulatory Point of contact for assigned products.
• Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products.
• Partnering with clinical, safety and medical, for critical activities supporting product development and maintenance including regulatory input to clinical development programs, PMCs/PMRs, PASS, PAES, risk/benefit assessments, RMPs, PSURs etc.
• Serving as a member of the Product Labelling Team, contributing to the development and update of the Target Product Label and CCDS.
• Provides strategic regulatory expertise in label negotiations for products assigned during registration and maintenance, including local and regional labels, as appropriate.
• Driving development of key Regulatory contributions and fit for purpose submission packages in collaboration with partner lines.
• Authoring regulatory contributions such as meeting requests, sections of the dossier, query responses, as applicable, ensuring business needs and quality standards are met and contributions are provided in accordance with agreed timelines.
• Ensuring regulatory plans are monitored, progress is communicated to Senior leadership and any risks (from emerging technical data, changing internal objectives or external impacts) are clearly communicated and mitigated where possible.
• Developing and maintaining constructive working relationships with Health Authority contacts.
• Organize, lead or participate in meetings with regulatory agencies, as appropriate.
• Business and Industry Leadership Supporting regulatory Due Diligence activities for business development opportunities.
• 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.
• Governance and Compliance Ensuring all regulatory requirements and/or commitments are met for obtaining and maintaining Marketing Authorizations.
• Ensuring business compliance and implementation of and adherence to regulatory standards.
• Implementing systems, processes and procedures relating to regulatory productivity improvements, ensuring that these facilitate the sharing of information and learnings within regulatory and the broader organization.

Minimum Qualifications

• B.S. Scientific Degree required.
• An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.
• Relevant Global and/or Regional regulatory experience Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation.
• 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.
• Proven ability to deliver to time, cost, and quality standards.
• Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical, other cross functional partners and senior stakeholders to achieve objectives.
• 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 deliver in a highly matrixed organization.
• Strong written and verbal communication skills.

Desirable Experience

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.

Benefits

• 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.
• 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.

Equal Opportunity

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.

Location

Viatris is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, and Hyderabad, India.