Regulatory Affairs Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gvl9o

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Job Title: Regulatory Affairs Specialist

Job Requisitions No.: 18302

Job Description:Role Details

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.

The Role

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.

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

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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Requisition ID: [[id

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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gvl9o