Regulatory Affairs Consultant - MAA Labelling
Belgium, Remote Additional Locations: Wavre, Walloon Brabant, Belgium Job ID R0000021308 Category Regulatory / Consulting Date Posted 03/22/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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.
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