Job Description

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; 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 Regulatory Intern - Regulatory Strategy and Policy Europe role will make an impact:Develop an oversight of Regulatory Policy activities across Europe:

+ Support the team with Policy Paper and Legislation review
+ Track the requests from Medicines for Europe (MfE) and help to coordinate the response
+ Assist to collect the feedback to any surveys / requests for information from Health Authorities / MfE / National Trade Associations / Internal Stakeholders
Provide support with Regulatory Intelligence and Competitive Intelligence activities. Maintain submission strategy tracker up to date. Maintain Reg Fees Calculator and Requirements for Scientific Advice up to date. Help to consolidate the input for national phase timelines, as required. Provide the support with regulatory input to Trademark clearance process for the brand names. Develop an overview of the brand name requirements across European markets. Assist with Marketing Authorization Applications' Performance review for all pending and completed Viatris' group procedures. Support the MA withdrawal process activities and tracking, as required. Provide support to analysis related to Union's Critical List of Medicines. Assist Line Manager by supporting departmental initiatives as may be required.
Develop an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and liaison with Competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained. Focus: EU markets, United Kingdom, Switzerland, and few non-EU markets
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:The candidates should be at their second university degree year, currently enrolled in an accredited college or university in a life sciences degree course, or recently completed a life sciences degree course. Excellent IT skills with proficiency in Microsoft applications (especially Excel, Word and PowerPoint), previous experience working with databases and document management systems would be useful. Previous experience in Regulatory Affairs considered an advantage Interest in Regulatory Strategy and Policy welcome Working proficiency in English language

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.
What we offer:Top Employer Accreditation, demonstrating that we provide excellent people policies and practices Competitive compensation package inclusive of annual discretionary bonus Focus on career progression with growth and development opportunities Hybrid work model Emphasis on Health and Wellness programmes 100% paid medical insurance and Employee Assistance Programme Life cover Excellent employer-matched pension scheme with Viatris contributing up to 11% 2 paid volunteer days per year

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.