Specialist Electronic Submissions

4 months ago

Hatfield, United Kingdom Viatris Full time

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 Specialist, Electronic Submissions role will make an impact:
- Publish Marketing Authorisation (MA) Applications and all associated maintenance submissions for new and existing products in eCTD format or NeeS format, as required, in a timely manner to meet deadlines and Service Level Agreements.- Perform technical validation of electronic submissions to ensure compliance with externally set criteria before delivery to the Regulatory Users for internal review/approval, dispatch to Health Authority and archiving of each submission within agreed timelines.- Act as point contact / Subject Matter Expert (SME) for publishing queries within the Central RA, EU Affiliate teams and cross-functional disciplines- Contribute to the creation and maintenance of internal guidelines for regulatory systems and provide system/process training within scope of this role- Develop and maintain a working knowledge of publishing software and other regulatory systems within scope of this role

About Your Skills & Experience- Bachelor’s degree with focus on Information Management, Bio Science, Business Administration or equivalent preferred- Profound knowledge in the regulatory operations sector, especially in publishing and dossier submission management or related areas- Expertise with MS Office, Adobe Acrobat Professional, Document Management Systems (DMS), eCTD Publishing software and registrations management systems and associated global publishing processes and related regulations- Personally, you are characterised by your independent, proactive, and results-oriented work style and your ability to collaborate in cross-functional teams and a demonstrated ability to quickly learn new technology

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- 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

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

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.

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