Regulatory Affairs Consultant - MAA Labelling

We are seeking an experienced Regulatory Affairs Consultant to join our team. As a Regulatory Affairs Consultant, you will be responsible for providing expertise in registration Regulatory Affairs, with a focus on Global Regulatory (Clinical/Safety) and Global Labelling. This role will require the successful candidate to complete variations and renewals applications at the country level (Belgium, Netherlands, and Luxembourg).

Job Responsibilities

• Utilize your previous experience in registration Regulatory Affairs 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 Discipline

• A few years of experience in a CRO/Pharma

• A few years of relevant experience in submissions of variations and review of the labels and notices. 3-5 years in registration Regulatory Affairs to support Global Regulatory (Clinical / Safety) and Global Labeling processes.

• Client-focused approach to work

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Critical thinking and problem-solving skills

• Proficiency in English, Dutch, French. German would be a plus.