Regulatory Affairs Manager BE & UK at Sanofi

• Regulatory Affairs Team is new joint Science BE-UK team. Different kind of people, different backgrounds, ages, characters,…Strong as a TEAM, always helping each other.

Main Responsibilities

• Prepare, submit, and follow up registration applications
• Ensure that the internal databases for the products in its portfolio are constantly up to date, compendia and repertories, filing, ...
• Establish and develop an internal network of informal contacts with colleagues from the Belgian and UK Science Team (Pharmacovigilance, Quality, Medical Information). And building an external network of informal contacts with the local Health Authority and local/EU Trade Associations
• Review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with current legislation and registered particulars and take action, to secure regulatory approval where necessary. And oversee the creation of packaging in accordance with regulations and internal guidelines on the subject
• Develop a comprehensive understanding of the regulatory requirements for marketing authorisations in the EU (specifically Belgium and UK) to enable regulatory submissions to be compiled in line with the current requirements and on a continuous basis, implement national and European regulations, directives, and circulars
• Give regulatory advice or recommendation to relevant business partners so that appropriate development or marketing plans may be established
• Support activities to ensure regulatory compliance, identifying, highlighting and resolving issues where necessary
• Communicate with supply chain to ensure regulatory strategy is implemented within agreed timeframes to achieve an uninterrupted supply of compliant product to the market
• Participate in the preparation of Standard Operating Procedures

About You

• Scientific background is an added value
• A few years of relevant experience of regulatory management in pharmaceutical company (medicinal products) - obligatory
• Ability to prioritize, plan, networking, willingness to learn, adaptability, excellent communication skills, organizational skills
• Fluency in French, Dutch and English is mandatory