Regulatory Development Specialist

1 settimana fa

Milano, Italia Recordati S.p.A. A tempo pieno

Recordati is looking for a Regulatory Development Specialist with a Master/PhD in Pharmacy, Life Sciences or equivalent and an experience of at least 8 years in a similar role in a in consulting or pharma industry.

Main tasks:

- Manage data collection and reporting on the Consolidated Non-Financial Statement;
- Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to internal and external stakeholders;
- Advisory on preclinical, CMC, requirements for regulatory approvals;
- Drive and manage the key development regulatory processes including orphan drug designations, breakthrough designations, PIP/PSP strategy;
- Prepare and maintain core clinical trial dossiers in accordance with applicable regulatory requirements;
- Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, Investigator’s Brochure, clinical trial justifications with minimum support of senior staff;
- Prepare deferrals requests in relation to the new EU CTR regulation and CRS (UK);
- Interact with internal and external stakeholders to provide regulatory guidance and strategic input for clinical trials;
- Strategically plan and oversee global country submissions;
- Ensure accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs;
- Deliver regulatory training/presentations as required.

Hands-on experience and sound understanding of the regulatory processes, experience with development projects (including CTAs and/or INDs, PIPs, ODDs, authority meetings) and global regulatory experience are requirements for this position.

Fluency in English is required.

Location: Milan.

About the company
- Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock, with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, in Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases.Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.

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