(Senior) Regulatory Affairs Associate - Belgium
Want to know company name or location? Company managed [?]
Purpose of the Position:
- Preparation and follow-up of global CTA and IND submissions, including responses to Authorities and Ethics Committees
- Informed Consent Form development and review
- Execute oversight on CRO regulatory activities with respect to clinical trial authorisations, including oversight on (e)TMF maintenance
- Tracking of and reporting on CTA/IND submission and approval status
- Maintenance of public study and study results registries such as clinicaltrials.gov and EudraCT.
- Update and track regulatory documents throughout product development
- Review of technical documents including (clinical) study protocols, (clinical) study reports, regulatory submission documents ( Investigator Brochures, IMPD, IND), scientific presentations, posters, abstracts, and manuscripts with minimal guidance.
Skills, expertise and contribution:
- Accountability: exercising judgment/impact of decisions/consequence of error – job is based on the information the job holder gets.
- If the information is correct, the writer is expected to write correct documents.
- Knowledge of EU and US regulatory environment for clinical trials
- Willingness/ ability to work in a matrix environment
- Strong initiative and ability to work with minimal supervision
- Detail oriented, methodical and goal driven
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Strong communication, organizational and project management skills, team player
- Proficiency in Windows and Microsoft Office (Word, Excel, Access, Power Point) and publishing tools
- Excellent knowledge of English (spoken and written)
- Writing skills : Highly proficient
- University degree (Medical, Pharmaceutics, Biomedical Sciences…)
- Expected experience: Minimum of 3 years of relevant experience in (clinical) Research and Development within the pharmaceutical or biopharmaceutical industry.