Regulatory Affairs Specialist
il y a 2 semaines
**Introductie**:
One of our clients based in Mechelen, active in pharma consulting of specialized services for the pharmaceutical, biotech and medical device industries, is looking for a regulatory affairs specialist.
**Jobomschrijving**:
- Obtain & maintain perfect knowledge of applicable legislation
- Stay up to date with scientific developments relevant for the portfolio of the clients.
- Preparation of regulatory dossiers while ensuring that the dossiers are processed in accordance with the regulations in force and in compliance with the commitments made to clients
- Preparation of submission of European dossiers in eCTD format (CP, MRP/DCP, renewals)
- Participate in working meetings with clients to solve the client’s issues
- Be actively involved in internal meetings with Pharmalex project teams.
- Acting Pro-actively in those meetings
- Participate in audits or diagnosis of dossiers
- Submit PSUR/PSUSA
- Control packaging and labelling texts
- Participate in archiving activities
- Comply with relevant quality procedures
**Profiel**:
- Successful completion of Pharmacist’s diploma or a scientific Master’s degree (in Regulatory Affairs), or in some cases a specialized bachelor’s degree
- 1 to 3 years of professional experience and project management experience
- Good Knowledge of English on top of Dutch or French.
- Good knowledge of European regulatory requirements for medicinal products
- Distinctly strong service orientation
- Content-related experience in several relevant areas of Regulatory Affairs
- Ability to manage one or several projects with limited guidance
- Autonomous approach to work, flexibility and dedication
- Diplomacy, ability to communicate and fit in an international and multicultural environment
- Strong sense of responsibility, organizational skills and intrinsic motivation
- Good knowledge of the MS-Office package
- Professional communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise
**Aanbod**:
They offer a competitive salary package.
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