Responsibilities
- The Global RA Manager 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
- 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.
- 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
Qualifications
- At least 3 years of experience within Regulatory Affairs
- Professional skills needed to hold the position :
- General knowledge of the drug development process, drug regulations, regulatory procedures, and drug development guidance
- Effective in verbal and written communication
- Able to work in a matrix and in multicultural teams
- Result-driven
- Listen, social intelligence, and diplomatic
- Good knowledge of regulatory tools for tracking and archiving
- Good knowledge of basic Office programs
- Ability to prepare PowerPoint presentations
- Ability to search and retrieve information from the worldwide web
- 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
- Written and spoken English
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