Regulatory Affairs Specialist
hace 2 semanas
**Regulatory Affairs Specialist**
**Major Tasks**
- Provides operational support to Regulatory Affairs Management in active projects such as local regulatory strategy for New Drug Applications, local preparation for the New Molecules Committee and other projects.
- Propose the local regulatory strategy for maintenance projects of the active registrations by ensuring correct regulation interpretation in order to compile the dossier according to the local requirements for submission as:
- Labeling variations: Prepares the local prescribing information and coordinates revision and approval with Medical Affairs. Prepares the regulatory submission dossier.
- CMC Variations: Prepares the technical dossier for submission and ensures. Local Quality Responsible revision/sign for submission.
- Administrative/Other variations: Prepares the dossier for submission according to the change and ensures revision/sign of the local quality responsible for submission.
- In case additional global support is required, coordinates the information request with Global Regulatory Affairs of legal and technical documents required in the Dossier for submission according with the approved strategy proposal.
- Also, operate the corporate regulatory systems aligned with the applicable processes and provides support by artwork revision in regulatory compliance.
- To provide relevant insight through regulatory policy & intelligence information to be share with RPI Manager.
- To update, improve and maintain the regulatory policy & intelligence information in the RPI databases.
- Contribute with analyses for projects deliverables including reports, and presentations.
- Proactive monitoring and screening of draft and final legislations/ guidelines and other information on regulatory matters issued by Mexican government and health regulators in order to identify those that may have a relevant impact for Bayer.
- Proactive monitoring the precedence and competitor regulatory intelligence in Bayer s therapeutic areas and in licensing activities including gathering and collecting competitor regulatory intelligence and Health Authority benchmarking data on performance measures.
**Skills**
- University degree in Pharmaceutical/Chem science with at least 5 years experience in regulatory affairs in Pharmaceutical Industry and Medical Device Industry.
- Strong overview of the current Mexican regulatory environment and Mexican regulation knowledge in drug products and medical devices.
- Strong ability and understanding of Technology enabled analysis and reporting tools.
- Ability to analyze complex regulatory information and to present this clearly.
- Strong verbal and written communication skills in English.
**Período de aplicación**:
- 23 Marzo al 10 Abril, 2023**Código de referencia**:
- 789384**División**:
- Pharmaceuticals**Ubicación**:
- Mexico : Ciudad de México : Ciudad de México**Área funcional**:
- Registro Farmacéutico**Grado de posición**:
- VS 1.1**Tipo de empleo**:
- Permanente**Tiempo de trabajo**:
- Full Time, Indeterminado
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