Regulatory Affairs Senior Specialist

Viatris; Dublin; Sur place; EUR 60 000 - 76 000; Plein temps

Avantages offerts par ce poste

Career progression

Health insurance

Pension

Bonus scheme

Work-life balance

Résumé du poste

Viatris is seeking a Regulatory Affairs Senior Specialist to join the GSM Team in Dublin. The role supports Global Submission Managers by planning submissions, troubleshooting issues, and maintaining quality standards.

You will prepare documents per Viatris formatting and agency requirements, QC outputs, and participate in continuous improvement projects. The ideal candidate will have computer literacy, strong written and spoken communication, and relevant experience in submissions.

Qualifications

• Educational background Computer Literacy with Microsoft Office Suite.
• Good Communication skills (written & oral).
• Relevant experience/skillset in regulatory submissions or GSM is desirable.

Responsabilités

• Assist in submission planning and scheduling within the GSM team.
• Prepare submission documents following Viatris formatting standards and agency requirements.
• QC of published output for technical conformance and fix validation issues as directed.
• Contribute to special projects and continuous improvement initiatives.

Connaissances

Communication skills

Computer literacy

Outils

Microsoft Office

Description du poste

McDermott Laboratories Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally.With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.We have been included on number of award lists that demonstrate the impact we are making.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 Senior Specialist in GSM Team at Viatris plays a critical role in supporting the Global Submission Managers with their role by assisting in efficient submission planning, troubleshooting technical issues, maintaining submission quality standards, and contributing to continuous improvement initiatives.

Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Senior Specialist role will make an impact: Contribute to submissions’ support as directed. May attend team meetings with discretion of Manager/Senior Manager. Scheduling of submissions in the various available Systems. Prepare submission documents in alignment with Viatris formatting standards and Agency requirements. QC of published output for technical conformance. Correcting any validation issues as assigned by Manager/Senior Manager. Contribute to 'Special Projects' within the GSM Team as requested. Contribute to continuous improvement workstreams and initiatives as requested.

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: Educational background Computer Literacy with Microsoft Office Suite Good Communication skills (written & oral) Relevant experience/skillset 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:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

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-responsibilityNone

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.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.