Cenetogrel LLC
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

Every day, we rise to the challenge to make a difference and here’s how the Director Regulatory Operation (m/f/d) Viatris Innovation role will make an impact:

• Providing line management across sites: strategic leadership, direction, mentoring, coaching and guidance to direct reports globally.
• Overall management of DRA operational resources including long-term prioritization to effectively support all operational activities (including editorial activities and all clinical trial submissions).
• Strategically driving the development and implementation of efficient business processes for managing worldwide regulatory submissions (eCTD, electronic and paper, datasets, editorial activities).
• Driving operational excellence, compliance, integrity and alignment through adherence to Idorsia’s policies, SOPs, WIS, ICH GCP and FDA, EU and international regulatory requirements.
• Establishing and managing global labeling function with the creation of inspection-ready global quality processes
• Proactively manage the assessment, development, update and implementation of DRA-related operational tools and systems, including acting as the system Business Owner or deputy, as needed

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 bachelor’s degree with preference for secondary degree or equivalent university education/degree in life science or healthcare
• Minimum 10 years of relevant experience in clinical development and regulatory affairs operations (EU and US), with at least 3 years’ experience in a line management capacity
• Excellent working knowledge of the US and EU regulations and guidelines governing both paper and electronic (eCTD) submissions, and the ability to interpret and implement them as appropriate
• Familiarity with electronic publication tools and electronic document management systems
• Solid understanding of dataset requirements for US submissions
• Solid knowledge of global regulatory requirements and regulations for the conduct of clinical trials
• Fluent in English; fluency in other languages is advantageous

What we offer you:

• Friendly working atmosphere in a great team, Great Place to Work® certified
• Development opportunities within an international company

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. You may just be the right candidate for this or other roles.
Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
https://www.viatris.com/en/about-us/corporate-responsibility
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.
Viatris is an Equal Opportunity Employer.

LI-Remot

Every day, we rise to the challenge to make a difference and here’s how the Director Regulatory Operation (m/f/d) Viatris Innovation role will make an impact:

• Providing line management across sites: strategic leadership, direction, mentoring, coaching and guidance to direct reports globally.
• Overall management of DRA operational resources including long-term prioritization to effectively support all operational activities (including editorial activities and all clinical trial submissions).
• Strategically driving the development and implementation of efficient business processes for managing worldwide regulatory submissions (eCTD, electronic and paper, datasets, editorial activities).
• Driving operational excellence, compliance, integrity and alignment through adherence to Idorsia’s policies, SOPs, WIS, ICH GCP and FDA, EU and international regulatory requirements.
• Establishing and managing global labeling function with the creation of inspection-ready global quality processes
• Proactively manage the assessment, development, update and implementation of DRA-related operational tools and systems, including acting as the system Business Owner or deputy, as neede

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Minimum bachelor’s degree with preference for secondary degree or equivalent university education/degree in life science or healthcare
• Minimum 10 years of relevant experience in clinical development and regulatory affairs operations (EU and US), with at least 3 years’ experience in a line management capacity
• Excellent working knowledge of the US and EU regulations and guidelines governing both paper and electronic (eCTD) submissions, and the ability to interpret and implement them as appropriate
• Familiarity with electronic publication tools and electronic document management systems
• Solid understanding of dataset requirements for US submissions
• Solid knowledge of global regulatory requirements and regulations for the conduct of clinical trials
• Fluent in English; fluency in other languages is advantageou