Specialist Electronic Submissions
2 weeks ago
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.
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.
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
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.
- 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
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 visitSustainability 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.
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