Internship Regulatory Affairs

The role has primary responsibility for supporting all local regulatory affairs workflow including preparation of dossiers and applications for new registration and maintain existing products life-cycle as well as applying the pharmacovigilance policy under the supervision by line Manager. Support RA and QA team in: Preparation of dossiers and applications to register new products and maintain existing products life- cycle Preparation of parallel import applications for national and central import procedures. Supporting the relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications. Submission of Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions) Artwork revision process, i.e. requesting, proof reading, approval and implementation of artwork Close cooperation with supply chain and marketing department to ensure product launch and marketing materials approval from regulatory perspective. Maintain and coordinate various local databases. Close contact with headquarters RA department to prioritize the new procedures and upcoming changes. Support to Tender Dept. for qualitative related documentation. Maintenance of RA/QA internal databases and product master data Support with PQC and MI The person

At least 6 months 1-year professional experience on similar position or internship in RA Department in pharmaceutical company or national competent authority Knowledge of pharmaceutical law and the required documentation for pharmaceutical product An understanding of the drug registration and reimbursement procedures Strong analytical skills Being well organized and flexible Excellent knowledge of MS Office, especially Excel Fluent English (B2 is minimum) Clearly define any essential or desirable

Qualifications: pharmacy, biotechnology, biology, chemistry or similar. Certifications or accreditations: Master concerning Regulatory Affairs and P&R could be a plus Those listed as essential will form part of the key criteria for selecting candidates for the role.

#J-18808-Ljbffr