Regulatory / Labelling Coordinator - Bristol Myers Squibb - Braine-l'Alleud

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Bristol Myers Squibb is looking for a Regulatory/Labelling Coordinator to provide support to the ERPMs for labelling activities of the Centrally Approved Products:

• Coordinate translations of the product information (PI) and linguistic review

• Interaction with local regulatory, translation vendors, European Medicines Agency (EMA)

• Create translation projects in translation tool

• Coordinate Maltese translations with external vendor

• Gather information required to update printed packaging (artworks)

• Initiate, coordinate and track the artwork updates and approvals,

• Interaction with different departments, e.g. Local Regulatory, Supply Chain and manufacturing operations sites

Additional ad-hoc support tasks:

• Request EMA Certificate

• ERPM metrics preparation

• eTime coordinator

• Paper archiving (of European Commission Decisions)

• Ad-hoc support to ERPM (CARA, notification submissions cross-products, Verity)

List of Requirements

• 3 years experience in pharma industry (experience in Regulatory is a plus).

• Be fluent in English with good communication skills.

• Be very well organised and detail oriented.

• Be eager to work in a team and to provide support.

• Have good knowledge of Microsoft Office, Adobe Acrobat.

• Be interested to work with and learn using technical tools (e.g. translation management tool).

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.