Director, Global Regulatory Strategist - Allergy/Cardiovascular Portfolio

Director, Global Regulatory Strategist - Allergy/Cardiovascular Portfolio

Viatris

Dublin, Inverin or Hatfield

The Role & What You Will Be Doing

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

The Director, Global Regulatory Strategist is a senior level position, recognized as an expert for global regulatory strategy in support of the Viatris Allergy/Cardiovascular portfolio.

Key responsibilities for this role include:

• Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, 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);
• Developing Global/Regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products including novel, 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;
• Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development;
• 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 on time to the required quality standards;
• 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;
• Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies;
• 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 mitigated;
• Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author sections of the dossiers, as applicable;
• Developing and maintaining constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions;
• Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards;
• Understanding current global and regional evolving regulations and guidelines with the ability to assess these requirements' impact on products/projects. Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, partners and trade associations.

About Your Skills & Experience

• A higher degree, master’s or equivalent, is preferred;
• Extensive regulatory experience within a Global Regulatory Affairs Strategy position with hands-on authoring experience (initial registrations or post-approval variations);
• Elevated level of knowledge of development & commercial activities to assess clinical, scientific & regulatory merits of information, commitments and data to lead teams and/or complex projects, with a focus on Allergy and Cardiovascular products;
• Extensive clinical and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Knowledge of Global applications for applications for Allergy and Cardiovascular products and product development an advantage;
• Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives;
• Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Clinical, Non-Clinical, Safety, Medical, Commercial, R&D, Legal and senior stakeholders to achieve objectives;
• Allergy and Cardiovascular therapeutic areas an advantage.