Regulatory Affairs Senior Analyst

About the role

Viatris is hiring a Regulatory Affairs Senior Analyst in Costa Rica. The role assists the Regulatory Affairs Senior Analyst in providing leadership and strategic direction for a specific in-country portfolio. It is a contracted position with a fixed term of 1 year.

Key responsibilities

• Coordinate and follow up on product registration to ensure timely approval according to the registration plan.
• Follow up on packaging artwork development within legal timelines, in line with Logistics, Marketing and product suppliers.
• Maintain registration licenses, regulatory information, correspondence and documentation, keeping them current, correct and confidential.
• Support the Regulatory Affairs Manager in routine regulatory activities, including escalating critical issues, guiding Regulatory Analysis and implementing new procedures.
• Handle correspondence with overseas and local parties to obtain or supply information and documents.
• Take part in meetings with BoH and trade associations, and stay updated on applicable regulations.
• Coordinate special projects and ensure systems comply with SOPs.
• Work with Quality and Supply so that packaging, product appearance and finished product specifications meet regulatory approval.

Required profile

• Pharmacist degree.
• Appropriate regulatory affairs experience; minimum 3 years preferred.
• Demonstrable experience across the drug discovery, development and commercialization lifecycle.
• Proven ability to manage regulatory issues and deliver in a complex matrix environment.
• Fluent English, written and spoken.

Required skills

• Knowledge of NDA submission processes.
• Product life cycle management activities.
• Ability to deliver consistently to time, cost and quality standards.