Senior Regulatory Affairs Specialist - Ficarazzelli-Bagni Italia - Philogen S.p.A.

Descrizione

Senior Regulatory Affairs Specialist

We are seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to strengthen our regulatory affairs function. The successful candidate will report to the Head of Regulatory Affairs and play a key role in the development and execution of regulatory strategies supporting the development of our products.

• Develop and contribute to regulatory strategies for clinical development programs and product lifecycle management.
• Lead activities related to preparation, submission, approval of regulatory dossiers with global authorities (EMA FDA).
• Cross-functional coordination including INDs CTAs MAAs variations scientific advice procedures eCTD submissions maintenance activities approved products.

The ideal candidate should have:

• University degree Life Sciences Pharmacy or scientific discipline.
• At least 8–10 years experience Regulatory Affairs pharmaceutical biotechnology industry Strong experience global submissions regulation lifecycle ICH guidelines EMA FDA regulations eCTD systems solid understanding workflows business processes compliance protocols company objectives national international laws contract salary proportional qualification proactive spirit strong written verbal communication skills fluency English (written spoken).