Regulatory Affairs Expert

Regulatory Affairs Expert - Sanofi - Budapest - Hybrid

The Regulatory Affairs Expert (RAE) supports the regulatory compliance for marketed products by means of a correct handling of all regulatory activities for the product portfolio under the RAE’s  responsibility. This included the support of product license’s maintenance and site registration.

The RAE evaluates the compliance of new products (in-licensing project and development projects) with both the regulations in force and with the internal requirements.

The RAE Ensures the role of regulatory expert for all regulatory topics and projects for the assigned CMO’s.

Duties

Prepares the technical dossiers for registrations in collaboration with GRA  teams and external partners and ensure data entry in regulatory database for :

• Initial registration
• Site registration
• Territory extension
• Variation
• Renewal
• Responses to authorities

• Ensures the compliance of the Non Drug products (Medical Devices, Nutraceuticals and Cosmetics) according to the applicable regulations and the Sanofi quality requirements for development projects and marketed products.
• Contributes to the Due diligences for in-licensing projects and to the preparation of the launch for new development project for all regulatory aspects.

• Ensures the change control management in the appropriate tool and evaluates Change Control with regulatory impact in collaboration with GRA and /or Affiliates Regulatory focal point.

• Ensures the regulatory intelligence and develops the team expertise and evaluates the impact on the portfolio under RNDM responsibility in the case of any new regulations and guidance.

• Ensures the review of the regulatory part of the Product quality review if applicable.
• Coordinates the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs and CMOs.
• Contribute to KPIs reporting for activities under his/her responsibility
• Supports the Quality team, Innovation team, Supply Chain team and Transfer team for all regulatory aspects.
• Collaborates with Quality System team and IA CHC for establishing internal procedures and new Ways of Working for Non Drug products.
• Contributes to site inspections, audits and Site Quality review as appropriate

Background and experiences :

• Advanced Degree (Master) in a science/health field (e.g., Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent
• Experience in Regulatory Affairs or any relevant experience in Medical Devices, Food Supplements and/or Cosmetics.
• Should have broad knowledge of global regulations/guidelines on Medical Devices, Food supplements and/or cosmetics.
• Should demonstrate flexibility, proactivity and be able to communicate efficiently with various stakeholders internally and externally.
• Should demonstrate solid oral communication and writing skills in an international environment.
• Fluent in English.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.