Regulatory Affairs Senior Specialist - Belgium
Main responsibilities will include:
- Coordinate, prepare and follow-up the submission of regulatory documents for national or international clinical studies.
- Prepare or maintain technical files as necessary to obtain and sustain product approvals.
- Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
- Provide regulatory advice to project teams (compile key regulatory documentation, provide interpretive assistance)
- Participate to definition of regulatory strategy
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Draft product labelling, instruction leaflets and packaging.
- Participate in internal or external audits, inspections and provide post-inspection follow-up information as requested
- Write or update standard operating procedures, work instructions, and policies.
Requirements and competencies:
- Scientific degree in life sciences or pharmacy
- Minimum 5 years of experience in the field of Regulatory Affairs
- Solid knowledge of ICH guidelines, EU regulations required for Regulatory submissions and Good Clinical Practice (GCP) guidelines
- Strong organizational and communication skills (oral and written)
- Analytic capacity, attention to details, meticulous
- Solid writing and editorial skills
- Team player, strong interpersonal skills
- Able to work independently within your area of responsibilities
- Demonstrated ability to deliver results to the appropriate quality and timeline
To join a company with a very high growth potential, to integrate a very competent and motivated team, to collaborate to the development of innovative products in a very dynamic environment, attractive salary and benefit package.
We are a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. We currently have a headcount of 22 staff members, located at our headquarters in and in the laboratory.