Regulatory Strategist Director

3 settimane fa

Milano, Lombardia, Italia Viatris A tempo pieno

Vision for Regulatory Excellence
Viatris is a pioneering healthcare company that is redefining the industry. We believe in empowering people worldwide to live healthier at every stage of life. As a key player in the global healthcare landscape, we are committed to advancing sustainable operations and innovative solutions that improve patient health.

About the Role
We are seeking an exceptional individual to join our team as a Director Regulatory Strategist. This is a unique opportunity to make a meaningful impact on the lives of millions of people worldwide. As a Director Regulatory Strategist, you will play a pivotal role in developing and implementing global and regional regulatory strategies that drive business growth and ensure compliance with evolving regulations.

Key Responsibilities
- Develop and implement global and regional regulatory strategies that align with business objectives and ensure compliance with regulatory requirements.
- Partner with cross-functional teams to ensure regulatory contributions meet business needs and quality standards.
- Provide regulatory input to clinical development programs, risk/benefit assessments, and target label development.
- Serve 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.
- Ensure regulatory plans are monitored, progress is communicated to Senior Management, and any risks are mitigated.

Requirements
We are looking for a highly skilled and experienced individual with a proven track record in regulatory strategy and compliance. Key qualifications include:
- A Bachelor's degree in a scientific field (e.g., life sciences, pharmacy, or a related field).
- 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 is essential.
- 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 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.

About Viatris
Viatris is a global healthcare company that is dedicated to building a truly diverse, inclusive, and authentic workplace. 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. If you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

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