In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico.
**Responsibilities**:Provide guidance and support about Mexican and Central America legislationContribute to the regulatory activities performed.
Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.Contribute to the production of client administrative documents to be included in regulatory submissionsCompile regulatory dossiers in accordance with national requirements.Systems Management and AdministrationDocument and track regulatory submissions and regulatory authority approval.Provide regulatory support to clients and associate companiesLiaise with sponsor head-office and affiliate departments on regulatory issues.Provide review of packaging texts.Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.G., QRD compliance check).Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory servicesEducation & ExperienceBachelor's degree or more in a Life Sciences related field.
Pharmacy degree would be a plus.5+ years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service ProviderProfileHard/Technical skills:Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations)Knowledge of MX and LATAM regulation for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination productsNew registrations of drug products is preferable.Soft skills:Excellent organizational and interpersonal skillsExcellent communication skillsAbility to work well within a team and autonomouslyAbility to prioritize different workloads/multi-taskProcess orientated with good attention to detailSolution drivenFluency in Spanish and English