The minimum qualifications for this role are:
• University degree preferably in Pharmacy or Life Sciences.
• Previous 1-3 years of experience withing Regulatory department.
• Excellent Latvian and fluent English language skills.
• Diligence, accuracy and focus in daily activities.
• Effective cross-functional communication and collaboration skills.
• Efficient computer skills.

Every day, we rise to the challenge to make a difference and here’s how the Senior Regulatory Affairs Specialist (16 Month FTC – Maternity Cover) role will make an impact:
Key responsibilities for this role include:
• Represent Regulatory Affairs function in Latvia.
• Ensure regulatory compliance with internal and external procedures and regulations.
• Cooperate, liaise with and report to affiliate departments, external regulatory authorities, corporate head-office and manufacturing sites on regulatory issues, as applicable.
• Prepare documentation for all submissions, variations and notifications to local regulatory authorities.
• Provide required support for the new products introduction and implementation processes.
• Keep the internal regulatory databases up to date.
• Ensure translation of Summary of Product Characteristics (SPC), Package Leaflets (PIL) and labelling text into Latvian/ English in compliance with regulatory standards, country requirements and rules.
• Complete proof-reading of Latvian patient information leaflets and labeling texts against prepared artworks.
• Archive Regulatory documentation for company purposes.
• Provide the teams with the latest approved SmPC/ PIL packaging information.

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.