Fresenius Medical Care is the world's largest provider of dialysis products and services. Fresenius Medical Care is also the world‘s leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.
Fresenius Medical Care is looking for a Regulatory Affairs Specialist (M/W) in Casablanca.
Goal of function :
Coordinate and supervise Regulatory Affairs applications related to product Life Cycle Management (LCM) and/or New Drug and Devices Approvals (NDDA). Develop, review and update labelling and ensure RA compliance in promotional material according to local legislation and Standard Operation Procedures (SOPs). This role is serving as an interface between the HQ and the distributors and/or the governmental hospitals for all regulatory matters.
- Monitor regulatory environment and ensure full compliance with relevant legislation and with relevant legislation and with internal SOPs.
- Update and implement local regulatory procedures.
- Interact constantly with Health Authorities (HAs) to ensure timely approvals, detect regulatory trends and keep up-to-date with legislation at Morocco
- Maintain close interaction with local external stakeholders through an active presence in regulatory associations and similar forums.
- Proactively share regulatory intelligence with internal stakeholders on competitors’ products as well as on emerging regulations.
- Assess registration files, ensuring compliance of file content to regulatory requirements.
- Handle HAs or agents’ requests and demands on quality, clinical and non-clinical information according to FMC standards/SOPs
- Ensure timely submission and follow-up of labelling variations to the local HAs, in cooperation with the key stakeholders.
- Manage NDDA submissions in accordance with local regulation ensuring the files are prepared, and submitted in time.
- Maintain licence to operate in Morocco by timely management the renewals and LCM activities.
- Coordinate actions effectively and proactively with other functions to support product launches, LCM activities and supply in due time.
- Contribute to shape FMC’s position on local HA’ proposals and guidance in order to provide company’s input on regulatory initiatives.
- Maintain fluent interaction with regulatory associations and key regulators in order to reinforce FMC’s presence locally.
- Provide advice and recommendations to local Management on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.
- Ensure inspection and audit readiness for RA unit in terms of archiving and documentation in place.
Pharmacist degree or equivalent education with additional specialized qualification.
At least 1-3 years professional experience in a healthcare or healthcare-related business environment, ideally in an international company, in a regulatory role.
Highly professional attitude characterized by a result, quality, patient and customer oriented working style.
Excellent networker and corresponding strong business network.
Very high social competence, including excellent communication skills and based on a sincere personality.
Very strong structured methodical approach leading to pragmatic and effective solutions.
Willingness to learn andbuild know-how within a short period of time.