Regulatory Affairs Manager Europe / Regulatory Lead (m/w/d)

at  Viatris

Viatris Healthcare GmbH
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.
Every day, we rise to the challenge to make a difference, and here’s how the role Sr Project Manager will make an impact:
The Regulatory Lead in the EU Central Regulatory Submission Team is responsible to perform all Regulatory activities from development to maintenance of medicinal products in the Developed Markets (including non-EU markets). They will be providing Regulatory direction for their assigned product(s), maintaining a relationship as a strategic partner to internal and external stakeholders, providing regulatory advice to other departments of the company, as well as national affiliates. In this role the Regulatory Lead is responsible for the Regulatory submission strategy for assigned products.

To perform this job successfully, an individual must satisfactorily perform each essential duty:

• Responsible for the development and implementation of the regulatory strategy for assigned products for the whole spectrum of regulatory submissions (Branded-full / generic applications, national, MRP/DCP/CP) under supervision, if applicable
• Identifying region specific regulatory requirements and incorporating those into the regulatory strategy for assigned products and assigned markets
• Collaborate as regulatory interface in interdisciplinary cross-functional teams (e.g. Global Key brand team, respective submission teams, regulatory science team, launch team) providing regulatory direction and leadership for assigned product(s) and assigned markets
• Lead regulatory sub-team (incl. respective Label Lead and Regulatory Operations) and collaborate to ensure timely provision of regulatory deliverables and execution of regulatory submission strategy according to agreed plan
• Develop and support the overall Regulatory submission in collaboration with RA sub team (Label lead, Regulatory Operations) and cross-functional teams (Medical, Clinical / pre-clinical, PV, CMC) for new applications, variations and any life cycle activities, if appropriate, for any kind of submissions (Branded-full / generic applications, national, MRP/DCP/CP)
• Oversee and coordinate the preparation, submission and maintenance of Regulatory compliant high quality dossiers cross functionally for new applications, renewals and variation applications with documents/ modules (Module 1, 2, 3, 4, 5 ) provided by the relevant functions for assigned products. Writing administrative parts
• Manage effectively any Regulatory submission activities, national and EU procedures and prepare respective communication with affiliates and Health Authorities. Preparation and organisation of answers to submission-related health authority comments in collaboration with respective teams.
• Act as the contact to authorities on national and international level. Prepare, organize and participate at Health Authority/scientific advice meetings for assigned products/ projects

The minimum qualifications for this role are:

Completed university degree in natural sciences, i.e. Biology, Chemistry, Pharmacy

• At least 3 years of experience in Regulatory Affairs,
• Knowledge of essential European regulatory requirements,
• Ability to plan and execute regulatory projects with special consideration of the expertise acquired during education,
• Excellent communication skills, a real team player,
• Ability to establish working contacts with authorities,
• Excellent skills in English language,
• Practical knowledge of Microsoft Office programs (e.g. Word, Excel, Powerpoint).

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.

Please refer the Job description for details