Regulatory Affairs Specialist

Job Description:

« Engagé pour le progrès thérapeutique au bénéfice des patients » Servier est un laboratoire pharmaceutique international avec une implantation solide dans 150 pays et 22 000 collaborateurs. La croissance du Groupe repose sur la recherche constante d'innovation dans cinq axes thérapeutiques : les maladies cardiovasculaires, immuno-inflammatoires et neuropsychiatriques, le cancer et le diabète. Gouverné par une Fondation qui assure notre indépendance, Servier investit 25 % de son chiffre d'affaires (hors activité génériques) en R&D. Convaincus de la puissance d'une dynamique d'innovation ouverte, nous menons une politique active de partenariat avec d'autres laboratoires, des biotechs innovantes, des universités et des incubateurs de start-up et nous investissons dans l'e-santé avec notre structure interne WeHealth. * 4,6 milliards d'euros de chiffre d'affaires en 2019 * 100 millions de patients traités quotidiennement dans le monde grâce à nos médicaments * 2e laboratoire pharmaceutique français * 3 centres de recherche, 15 centres de recherche thérapeutique, 16 sites de production dans le monde 5 000 collaborateurs dans l'Hexagone : le siège, 2 sites de production, 2 instituts de recherche et un centre d'investigation L'implantation du futur Institut de Recherche Servier Paris Saclay confirme sa volonté de continuer à s'engager en faveur du développement économique local et de soutenir l'attractivité de la recherche française.
Leading French independent pharmaceutical Company, specialised in ethical medicinal products. 92% of Servier's sales are achieved internationally, with several subsidiary companies abroad. We are looking for V.I.E's, for our subsidiary in Panamá. Description of the mission: - Deputy for Local Coordination for Pharmaceutical Responsibility; Implementing all Pharma-SOPs and OPMs concerning local responsibilities into local procedures. - Deputy for ensuring the local regulatory compliance of third parties with pharmaceutical agreements. - Deputy Responsible Person for Product Quality Complaints, Responsible Person for Recalls at the subsidiary level. - Deputy for organizing the monthly quality complaints/PV meetings, for reconciliation between the LPV and the person responsible for products complaints and other potential sources of quality defect information (e.g. medical information department, etc.) - Deputy for organizing the monthly reconciliation meetings with the local Medical/Scientific information Department. - Provide support for organizing and/or coordinating contacts with Competent Authorities (CA), in particular urgent communication to Local Health Authorities in coordination with headquarters, in case of Urgent Safety Restriction, for example. - Implement and provide assessment on the local regulatory intelligence. - Provide support ensuring the compliance of all subsidiary activities including packaging items, medical information, PASS in accordance with current local regulatory requirements. - Provide support for being a contact point of the CA in case of subsidiary inspection. - Provide support in coordinating implementation, at a local level, of Risk Minimization Measures (such as dispatch of DHPC or educational material, prepared by CentEX WRA), and ensuring the traceability and archiving of these measures. - Deputy responsible for Promotional Material at the subsidiary level; create and develop the local procedure for the approval of promotional materials. - To recognize, record and report any potential pharmacovigilance information (such as adverse drug reactions) that the employee is made aware of and in line with Company procedures. ? To ensure that all medical enquiries are processed in accordance with the Company procedures. - To ensure all activities are conducted within the framework and full compliance of the internal Company procedures, FEDEFARMA Code of Good Practices and all applicable legislation aimed at minimizing the exposure and risk of the Company. - To always act in a professional manner, holding compliance with all local regulations and procedures (Global and Local) at the forefront of actions. - Ensure compliance with Servier's Code of Conduct. - To ensure completion of all training materials provided by Servier to collaborators in a timely manner. Duration of the mission: 9 months (renewable for a total duration of 18 months)

Candidate Requirements:

Educational background: Studies in Pharmacy, Medicine, or Health Sciences (required) Field of study: Biology, Pharmacy, Medicine, or related Health Sciences studies. Languages: Fluent in Spanish and English (required) Experience required: Ideally 1 or 2 years of experience in regulatory affairs activities and quality management system. Computer skills: Microsoft Office Package Soft Skills: Interpersonal relations, empathy, capability to adapt to different situations, teamwork, organization and time management