Global RA Specialist

2 months ago


Cary, United States Chiesi Farmaceutici S.p.A. Full time

Purpose

The Global RA specialist supports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs. Supports regulatory agency interactions, communications, and preparation of submissions. Main Responsibilities

Independently coordinates the request to Affiliates and Partners of the regulatory requirements applicable to supported regions or areas of responsibility. With guidance from Unit Head, assist in the identification of the EU and US regulatory requirements applicable to supported regions or areas of responsibility With guidance from Unit Head, assist in the preparation and presentation of regulatory information at internal project meetings; Contribute to global strategy via participation in GRT With limited assistance, confirm compliance with applicable regulations and guidelines to ensure suitability of regulatory applications for submission. Provide updates to internal documentation, as appropriate. With guidance, provides support to GMP, GCP, and GPV inspections from health authorities. With guidance supports pre-approval and post approval activities. With guidance maintains relationships with the health authorities, directly or via Affiliate/Partners. With guidance manages IMDD, Affiliate, and Partner relationship(s) to ensure efficient global execution. Experience Required

At least 3 years of experience within Regulatory Affairs Professional skills needed to hold the position:

General knowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidance Effective in verbal and written communication Integrity Able to work in a matrix and in multicultural teams Open and flexible Result-driven Listen, social intelligent and diplomatic Plan & organize Good knowledge of regulatory tools for tracking and archiving Good knowledge of the basic Office programs Ability to prepare PowerPoint presentations Ability to search and retrieve information from the worldwide web

Education

University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology Scientific secondary-school diploma with at least 5 years of experience within International Regulatory Affairs Languages

Written and spoken English

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