Regulatory Affairs Manager
We are urgently looking for a freelance/ contractor Regulatory Affairs Manager.
Are you available now? We would love to hear from you. Apply online or call us on 02/456 00 00.
Planning & follow-up of all regulatory activities for dedicated products. Compiling, submission and follow-up of registration files. Assure products are in accordance with pharmaceutical law.
Roles & Responsibilities:
- Preparation and submission of a marketing authorization dossier, or a change of such a dossier at the Belgian and Luxemburg authorities and the follow-up of this submission by having regular contacts with the authorities and manufacturers/dossier supplier.
- Coordinating extra studies required for the registration files (e.g. stability, validation of methods, BE studies) by having contact with the applicable operation sites.
- Maintaining the companies’ registrations by means of preparing, reviewing and submitting of renewals, Periodic Safety Update Reports, variations (analytical & clinical) and other updates for certain dedicated products.
- Management of the approved documents (amongst others by controlling the work performed by administrative assistants) and taking care of a correct and timely communication with regards to new or changed data of dossiers to other internal departments, to the Global Regulatory Affairs group or towards internal/external manufacturers.
- Coordinate changes related to packaging materials of the Belgian products and approval of these towards the packagers/manufacturers.
- Answering (by phone, in writing) of questions from doctors, pharmacists, patients, … regarding the quality or action of the products.
- Monitor and implement the changes in the Regulatory environment.
- Responsible for follow-up of all legislation related to medicinal products and non-medicinal products.
- Communicate with the other departments on all relevant regulatory issues.
- Supervise and if applicable train RA Assistant(s).
- Preparing launch of the new registered products.
- Planning, notification and post-approval activities of all non-medicinal products distributed by the company.
- Verify if current registration file complies with the production practice.
- Creation and/or review of Change Control Request and submit subsequent variations. Defining strategy for submission of analytical and safety variations.
- To be able to pinpoint a problem and to systematically look for additional information in order to solve it.
- Recognize significant information.
- Skilled in separating a whole into its elemental parts.
- Tenacity: to be able, despite resistance, to keep the effort until the goal is achieved.
- Pursue everything with energy, drive and need to finish.
- Has a strong sense of urgency and stays focused on what is most critical.
- To bring structure in time and space and setting priorities when tackling a problem.
- Can orchestrate multiple activities at once to accomplish individual/team and company goals.
- Fulfil a task with eye for detail.
- Resides in Belgium
- Languages: preferably ENG/FR/NL or ENG/FR(NL) or ENG/NL(FR)