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Global RA Specialist
2 months ago
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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