Regulatory Affairs Senior Analyst

hace 16 horas

San José, Costa Rica Viatris A tiempo completo

3866 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 Senior Analyst role will make an impact:
Job Summary

To assist Regulatory Affairs Sr. Analyst to provide leadership and strategic direction of specific in-country portfolio.

Key responsibilities for this role include- Coordinates and follows up on product registration concerned to ensure timely approval according to product registration plan.- Coordinates and follows up activities related to packaging artwork development, according to legal timelines, in alignment with Logistics, Marketing and product suppliers.- Maintains relevant registration licenses, regulatory affairs-related information/system, correspondence, and other relevant documentation for easy retrieval. Ensures that they are kept current, correct, and confidential.-
- Handles correspondence with overseas and local parties (both internal and external) in order to obtain or supply required information/ documents.- Participate in meetings with BoH and Trade Associations.- Be updated regarding regulatory legislations in force and encourage the team the understanding of their contents.- Coordinate special projects.- Ensures maintenance of relevant systems according to relevant SOPs.- Ensures compliance with all relevant company SOPs.- Coordinates RA activities in partnership with Quality and Supply to ensure that their packaging, product appearance and finished product specification comply with the regulatory approval.

The minimum qualifications for this role are:
- Pharmacist degree.- Appropriate Regulatory Affairs experience - minimum 4 years is preferred.- Proven ability to consistently deliver to time, cost and quality standards.- Fluent in English - written and spoken communication skills.- Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.- Proven ability to manage regulatory issues.- Regulatory experience including knowledge of NDA submission processes and product life cycle management activities.- Demonstrable experience of effective delivery in a complex matrix environment.

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.

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