Director, Global Regulatory Strategist – Based Anywhere in Europe
Director, Global Regulatory Strategist – Based Anywhere in Europe
Apply locations Hatfield, England, United Kingdom Zug, Zug, Switzerland Northern Cross, Dublin, Ireland time type Full time posted on Posted 11 Days Ago job requisition id R5653294 Generics [U.K.] Ltd.
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;
* 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
The Director, Global Regulatory Strategist is an emerging senior level position, recognized as an expert for global regulatory strategy in support of Viatris’ eyecare portfolio.
The purpose of this role is to:
* 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.
* Manage the preparation and submission of correspondence and applications to regulatory agencies. Organize, lead, or participate in meetings with regulatory agencies, as appropriate.
* Direct and/or indirect liaison with Health Authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitments.
* Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.
Every day, we rise to the challenge to make a difference and here’s how the The Director, Global Regulatory Strategist role will make an impact:
* Developing Global/Regional regulatory strategies and implementation plans for complex projects/products.
* Providing regulatory input to clinical development programs and risk/benefit assessments.
* Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products.
* Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS.
* Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers.
* Ensuring regulatory plans are monitored, progress is communicated to Senior Management and any risks are mitigated.
* Direct activities to ensure the required documentation is prepared to a high standard.
* Developing and maintaining constructive working relationships with Health Authority contacts.
* Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes.
* Understanding of current global and regional evolving regulations and guidelines.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
* Minimum of a Bachelor's degree (or equivalent). An advanced Scientific Degree may be an advantage.
* Extensive global regulatory experience (US/EU) required.
* Regulatory Affairs Professional Certification, preferred.
* Global Regulatory Affairs CMC strategy, with hands-on CMC authoring experience.
* Prior experience managing projects and matrixed teams.
* Elevated level of knowledge of development & commercial activities.
* Extensive technical, functional, and industry knowledge in shaping project strategy.
* Advanced understanding of current and emerging regulatory requirements.
* Proven ability to partner successfully with various functions to achieve objectives.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply.
Benefits at Viatris
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. Some of our benefits include:
* Excellent career progression opportunities
* Work-life balance initiatives
* Bonus scheme
* Health insurance
* Pension
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission.
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission.
Viatris is an Equal Opportunity Employer.
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