To reinforce the Regulatory Affairs department, active in Medicinal Products,
Medical Devices and Food Supplements, infarAMA is currently looking for a
Regulatory Affairs Officer
About infarAMA
infarAMA is an independent consultancy company providing high standard professional expertise in global regulatory affairs, quality assurance, vigilance and translation services to the health care industry within Benelux. infarAMA is headquartered in Strombeek-Bever and has a brand-new subsidiary in Aarschot.
Key responsibilities
- Assist and support the Regulatory Affairs department
- Prepare, verify and adapt product information
- Provide scientific support for marketing authorisation dossiers, notifications and technical dossiers
- Submit registration and notification dossiers to health authorities
- Manage the life cycle of the client portfolios (variations, renewals…)
- Proofread leaflets and labeling
- Support evaluation of promotional activities
- Maintain records and files
Required profile
- Scientific degree ((industrial) pharmacist, biomedical sciences or equivalent by experience)
- 1 to 3 years of relevant experience in a similar function in the pharmaceutical industry
- Ability to take up RP, QP or RIP responsibility is an asset
- Fluent in English, Dutch and French with excellent oral and written communication skills
- Strong knowledge of current software
- Enthusiastic, meticulous, methodological, flexible and reliable
- Able to work both independently and in teams
Offer
- A varied job consisting in challenging multi-disciplinary tasks in a dynamic and growing environment
- Competitive benefits and compensation packages
- Workplace in Aarschot or in Strombeek-Bever
Applications
Interested? Send your resume and application letter to p.vandenweghe@infarama.be.
For more information, feel free to contact us.