Regulatory Affairs Analyst
Encontrado en: Jooble MX O C2 - hace 2 semanas
Regulatory Affairs Analyst (Fixed Term) page is loaded Regulatory Affairs Analyst (Fixed Term) Postuler locations Mexico City, Mexico time type Temps plein posted on Offre publiée hier job requisition id R5646189 Viatris Healthcare México S. de R.L. de C.V
Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:
Accès : En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.
Leadership : En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.
Partenariat : En valorisant notre expertise collective afin de donner accès à tous à nos produits et 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.
Chez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.
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