Associate Regulatory Affairs Executive (12 months agency contract)

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 Associate Regulatory Affairs Executive role will make an impact:

• Prepare regulatory dossiers (registrations, renewals, variations) and then organize their submission to European health authorities:

• Prepare administrative documents, taking into account country-specific requirements, and compile dossiers (modules 1 to 5);

• Assist in drafting administrative and quality variation dossiers according to the department's needs and in collaboration with the Regulatory Manager;

• Prepare the dossier electronically in eCTD format based on the technical validation criteria defined in the European guidelines;

• Collaborate with the operational team for electronic publication and submission;

• Update regulatory databases and other collaborative tools.

• Use electronic document management systems and understand publishing tools.

• Participate in global projects to support the department.

• Other administrative tasks, as assigned.

• This position requires rigor and versatility, as well as a good knowledge of the regulatory field and European procedures in particular.

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:

• A two- or three-year post-secondary degree (or equivalent) and significant experience in a similar role. A scientific background would be an asset for dossiers preparation.

• Excellent relational skills, strong organizational abilities, a commitment to quality, and the ability to meet deadlines. You are self-motivated and also enjoy working as part of a team.

• English language as well as Microsoft Office 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.

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.