Regulatory Aaffairs Consultant

We are recruiting for a Regulatory Affairs Consultant to be based in Belgium.

You will be required to coordinate the compilation, review and submission of regulatory agency applications for international clinical trials in compliance with international regulatory requirements as well as internal and client standard operating procedures (SOP's). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.

Responsibilities:

- Acting as a local regulatory contact representing various MAHs in Belgium and France, especially covering all MAs related maintenance activities

- Acting as a local regulatory contact for clinical trials in Belgium and France.

- Preparation and quality control of core regulatory submission packages, preparation and quality control of local regulatory submission packages for submissions to RAs in Belgium and France to ensure regulatory compliance, accuracy and completeness. Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions.

- Interacting with Belgium and French regulatory authorities, as required; liaise with internal and external partners on assigned projects, provide internal and external regulatory consultancy.

- Preparation, review and approval of labels.

- Acting as Global Regulatory Lead for clinical trial applications coordinating regulatory activities on international multi-center trials (design, plan and schedule activities and deliverables; interact with client and project team), support and development of submission plans and strategy to regulatory authorities, oversight and support for response management.

- Supporting SME team or acts as the SME to provide content to client proposals and

scoping.

- Mentoring and training junior team members/new joiners QualificationsEducation:

Bachelor’s Degree in a Scientific Discipline, Advanced Degree Preferred.

Minimum Work Experience:

Several years of work experience in the regulatory affairs in clinical trial industry.

Skills:

• Fluency to communicate at a business standard verbally and in writing in Belgian, English and French language.

• Results Orientation

• Interpersonal Communication

• Teamwork & Collaboration

• Problem Solver