Regulatory Affairs Associate

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Description de l'emploi

The Regulatory Affairs Associate has the operational responsibility for registration of dossiers and maintenance of registrations. He/she has a key role to ensure products could be marketed in accordance with regulatory requirements and guidelines.

Registration & Submission Dossiers

• Responsible for the optimal preparation, submission and follow-up of registrations (NP, MRP, DCP). Always be pro-active and inform your direct Line Manager and/or the Central Regulatory Affairs group about issues. In case of issues, actively propose solutions. Ensure maintenance of registration dossiers (variations, renewals, PSURS) for which you are responsible.
• Interaction and close collaboration with other departments of the local (QA/PV/Medical Affairs) and European Central RA Organization to collect information necessary for submissions.
• Administrative support for pricing and reimbursement procedures, in line with the pricing and reimbursement strategy defined by the company.

Management of Regulatory Projects

• Actively participate in the management of regulatory projects and implement these. Interaction with other departments in the organization, RA colleagues in affiliated companies and headquarters.

Procedures & Compliance

• Create RA procedures and work according to those procedures/guidelines within the department.
• Assure a good collaboration between the RA department and QA and PV department in order to assure the compliance of marketed products with the current approved registration file. Ensure compliance with all regulatory requirements.

Profil

• Bachelor or master’s degree in health sciences or proven experience in the pharmaceutical industry
• 2 to 5 years of relevant experience in Regulatory Affairs with knowledge of national and international regulatory requirements and guidelines on pharmaceutical products
• Experience in an international pharmaceutical environment
• IT skills: NeeS & eCTD, CESP submissions, Microsoft Office
• Good trilingual (write, read, speak): Dutch, French and English
• Excellent organization and project management skills
• Capable to adapt in a fast-moving environment and able to deal with tight deadlines
• Excellent interpersonal skills to assist in liaison with other departments within/outside the group to support regulatory requirements
• Able to work pro-actively
• Be able to work autonomously
• Sense of responsibility and accuracy

Offre

Permanent contract