Director Regulatory Strategist

3 mesi fa

Milano, Italia Viatris A tempo pieno

VIATRIS ITALIA S.R.L.

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.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

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Every day, we rise to the challenge to make a difference and here’s how the Director Regulatory Strategist role will make an impact:
- Developing Global/Regional regulatory strategies and implementation plans for 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.- Partnering with project teams and other stakeholders (e.g. Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal) to ensure required regulatory contributions (briefing documents, Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) meet business needs and quality standards and are provided in accordance with agreed timelines.- Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development.- 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.- 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.- 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, communicated and executed on time to the required quality standards.- Developing and maintaining constructive working relationships with Health Authority contacts.- Supporting regulatory Due Diligence activities for business development opportunities.- Working closely with other Regulatory team members 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.- 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 Regulatory Leads and trade associations.- Ensuring business compliance and implementation of and adherence to regulatory standards.

About Your Skills & Experience- BS. 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 partner lines and senior stakeholders to achieve objectives.- Proven track record of success in negotiating

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