Regulatory Affairs Analyst
Encontrado en: Talent MX C2 - hace 2 semanas
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 Analyst role will make an impact:
The Regulatory Affairs Analyst is responsible for assigned core regulatory activities pertaining to the pool of marketing authorizations, including submissions new drug application, renewals, variations, query responses, as well labeling and artwork updates.
Additional supporting activities include promotional material review and request of ancillary documents for affiliates.
Key responsibilities for this role include:
Prepare dossiers according to local requirements, according to defined submission timelines, including query responses, and artwork and labeling updates.
Arranges and updates Local Labeling to ensure their conformity with internal procedures and local legislation.
As assigned, manages RA activities in partnership with Quality and Supply to ensure that their packaging, product appearance and finished product specification comply with the regulatory approval.
Responsible to provide regulatory information and detailed status related to the Marketing Authorizations under her/his responsibility.
Ensures maintenance of relevant systems according to relevant SOPs.
Ensures compliance with all relevant company SOPs.
Reviews and prepares promotional material.
Requests ancillary (CPP) documents of Toluca manufactured/package l-Upjohn products for affiliates.
Manages third party relationships with notary, translators, and clerk for Cofepris and Foreign affairs procedures.
The minimum qualifications for this role are:
Pharmacist degree.
Appropriate Regulatory Affairs experience – minimum 1 years is preferred.
Fluent English.
Knowledge of basic Microsoft applications and proficient in learning new systems.
At Viatris, we offercompetitivesalaries, benefitsandan 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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