Regulatory Affairs Executive (12 Month Fixed Term Contract) in Hatfield

locations: Hatfield, England, United Kingdom

time type: Full-time

posted on: Posted today

job requisition id: R5666234

Generics [U.K.] Ltd. We at Viatris view healthcare as it should be, not as it is. We act boldly and have unique conditions, making us a source of stability in a world of changing health needs. Viatris enables people worldwide to live healthier lives at every stage. We achieve this through:

• Access – delivering high-quality medicines that patients trust, when and where they need them;
• Leadership – taking sustainable actions and developing innovative solutions to improve patient health;
• Partnership – leveraging shared knowledge to deliver our 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 project management team is seeking a highly motivated Regulatory Affairs Executive to join our team on a 1-year fixed term contract. The successful candidate will support regulatory activities related to rebranding, post-approval variations, labelling updates and artwork updates across the EU and UK region. This role requires strong attention to detail, excellent organisation skills, and the ability to work collaboratively in a fast-paced environment.

Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Executive role will make an impact:

• Regulatory Submissions & Planning
  • Plan and submit Rebranding MRP/DCP variations according to agreed timelines and schedules.
  • Support the update of Common and UK Product Information (PI) texts, including labelling elements.
• Labelling & Artwork Management
  • Create UK artworks in TrackWise for assigned marketed products 8 weeks prior to submission.
  • Assist team members with artwork task creation and PI updates for their respective portfolios.
• Cross Functional Collaboration
  • Contribute to additional rebranding related activities as needed.
  • Participate in meetings with the Project Management team and affiliate markets to ensure alignment and timely execution.
  • Collaborate effectively with internal and external stakeholders to address regulatory and operational requirements.
• Tracking & Documentation
  • Track and monitor the progress of variation submissions and maintain accurate, up to date records.
  • Maintain the Master Project Tracker and compile relevant metrics for Project Management reporting.

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:

• Solid understanding of European Regulatory Affairs, including variation guidelines.
• Proven experience with European post approval variation submissions.
• Experience with MHRA artwork submissions is an advantage.
• Strong Excel skills and overall IT literacy.
• Exceptional attention to detail.
• Ability to manage tight deadlines while maintaining flexibility in a dynamic environment.
• Strong communication and teamwork capabilities.
• Fluent English, both written and spoken.

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
• Focus on career progression with growth and development opportunities
• Hybrid work model
• 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.

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, recognising that our actions affect the stakeholders and communities we serve.