Viatris UK Healthcare
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
Obtain and maintain marketing authorisations for products in UK. Perform any other regulatory activities as required by company strategy and provide support to Line Manager by supporting departmental initiatives.
Every day, we rise to the challenge to make a difference and here’s how the Associate
Regulatory Affairs Manager role will make an impact:
- Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues
- Prepare regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post-approval submissions
- Maintain marketing authorisations for an assigned product portfolio. Ensure on-time submissions for all safety related changes for assigned projects
- Keep databases and systems updated in-line with current SOPs so that up-to-date information is available for all assigned products
- Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities. Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives
- Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects
- Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through 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
- Provide mentoring and training to other members of the team as directed by Line Manager
- Maintain product information and artwork for designated UK marketed products within the correct system, to reflect current registered versions
- Ensure the eMC database is updated with any changes to approved SmPCs and PILs
- Create and maintain Abbreviated Prescribing Information, as requested, to support Marketing team activities
- Manage the Sunset Clause status for assigned UK Marketing Authorisations in line with local policy and UK requirements
- Represent the UK regulatory affiliate at internal and external meetings, as requested
- Support projects by acting as departmental project lead or participating in project teams relating to company projects and departmental initiatives
- On an ad hoc basis, carry out additional tasks on behalf of Managers.
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 BSc (or equivalent) in Pharmacy/Life Sciences or a related area
- Have proven experience in the Pharmaceutical Industry within a Regulatory environment (human medicines)
- Strong organisation and communication skills
- Proficient in Microsoft Office (Word, Excel and PowerPoint) and Outlook. Working knowledge of TrackWise and Documentum is preferred
- Excellent written and oral communication skills.
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.
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 the following on top of a competitive salary:
- 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
- Emphasis on Health & 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.
