About the job
- Location: Diegem (Belgium), alternatively Reading (UK)
- % Remote working and % of travel expected: 60 % at office – 40% from home (5 % of travel expected)
- Job type: Permanent, full time (min. of 80% would be acceptable)
About The Job
Join Sanofi Belgium CHC – Consumer Healthcare – as Regulatory Affairs Manager BE & UK. In this role you will lead the preparation, the submission and follow up registration applications to the Belgian and UK regulatory authorities, expeditiously and to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company’s plans and goals. You will also support the launch of new products and life cycle management of the existing portfolio.
About Our TeamThe purpose of the Consumer Healthcare (CHC) unit is to offer a healthier and fuller life to our consumers. This mission defines what we believe in and represents the true meaning of our work at Sanofi. With all this, we strive daily to bring our products to consumers to say goodbye to the flu, cold and cough, combat their allergies, be loaded with good energy, enjoy good intestinal health and take care of the little ones of the house Our goal is to continue innovating in favor of the health and quality of life of users, identifying their needs and providing the best possible solutions.
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.
- 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
- 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
Pursue progress, discover extraordinary.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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.