Regulatory Affairs Consultant - MAA Labelling > Zaventem > Joboolo BE :
Société : Parexel Lieu : Zaventem Flanders Site source : Talent BE
Job ResponsibilitiesUtilize your previous experience in registration RegulatoryAffairs to support Global Regulatory (Clinical / Safety) and Global Labeling processes.Complete variations and renewals applications for Belgium, Netherlands, and Luxembourg.Demonstrate knowledge of EU and country-specific regulations and be familiar with document management systems.Understand the Regulatory processes required to update labelling of a product, including different variation categories.Utilize familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks.Be knowledgeable about the triggers that lead to a CCDS update.Demonstrate some understanding of Periodic Safety Update Reports (PSUR) and their potential impact on labelling.Appreciate the relationship between labelling and artwork processes.Have knowledge of SmPC, PIL, and QRD requirements and EU linguistic review.Possess some understanding of EU readability and PIL (testing).Knowledge and experience required for the role:
Minimum of a Bachelor’s Degree in a Scientific or Technical DisciplineA few years of experience in a CRO/PharmaA few years of relevant experience in submissions of variations and review of the labels and notices.
3-5 years in registration RegulatoryAffairs to support Global Regulatory (Clinical / Safety) and Global Labeling processes.Client-focused approach to workExcellent interpersonal and intercultural communication skills, both written and verbalCritical thinking and problem-solving skillsProficiency in English, Dutch, French.
