Director, Global Regulatory Strategist -Allergy​/Cardiovascular Portfolio

Mylan Institutional Inc.

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 1billion 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.

This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.

• 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.
• Supporting regulatory Due Diligence activities for business development opportunities.
• Provide input to and adhere to departmental budget.

• Minimum of a Bachelor's degree (or equivalent). 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.
• A minimum of 8 years in regulatory and a minimum of 5 years of global regulatory experience (US/EU) required. A combination of experience and/or education will be considered.
• Global Regulatory Affairs strategy, with hand‑on authoring experience (initial registrations or post‑approval variations) - Minimum of 5+ years
• 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,…