Regulatory Affairs Assistant

at  Viatris

Upjohn Export B.V. sucursal Costa Rica
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.
Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Assistant role will make an impact:
Job Summary
The Regulatory Affairs Assistant is responsible for assigned support activities pertaining to a pool of documentation, archive, update information about translations, legal certifications, couriers and shipments to other countries, coordinate and has a strong communication with vendors and clients that supply service to the regulatory department.

Key responsibilities for this role include

• Coordinate translations, soft copies, couriers and paper print copies according to local requirements, and according to defined timelines and priorities.
• Responsible to provide regulatory information and detailed status related to systems.
• Arranges and updates local archive to ensure their conformity with internal procedures and local legislation.
• Ensure the best control about the bills and the payments of the regulatory department.
• Ensures maintenance of relevant systems according to relevant SOPs
• Ensures compliance with all relevant company SOPs.
• As assigned, manages archive activities in partnership with Quality and global operations control to ensure the best practices.

The minimum qualifications for this role are:

• Administrator, regulatory affairs assistant, legal assistant; Appropriate assistant experience – minimum 1 years is preferred.
• Attention to details.
• Organization.
• Customer service focus.
• Problem solving.
• Intermediate Excel level.
• Knowledge on archive environment and regulations about it.

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.

Key responsibilities for this role include

• Coordinate translations, soft copies, couriers and paper print copies according to local requirements, and according to defined timelines and priorities.
• Responsible to provide regulatory information and detailed status related to systems.
• Arranges and updates local archive to ensure their conformity with internal procedures and local legislation.
• Ensure the best control about the bills and the payments of the regulatory department.
• Ensures maintenance of relevant systems according to relevant SOPs
• Ensures compliance with all relevant company SOPs.
• As assigned, manages archive activities in partnership with Quality and global operations control to ensure the best practices

The minimum qualifications for this role are:

• Administrator, regulatory affairs assistant, legal assistant; Appropriate assistant experience – minimum 1 years is preferred.
• Attention to details.
• Organization.
• Customer service focus.
• Problem solving.
• Intermediate Excel level.
• Knowledge on archive environment and regulations about it