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Senior CMC Regulatory Consultant
Il y a 2 mois
Job Summary:
We are seeking a highly skilled Senior CMC Regulatory Consultant to join our team at Ividata Life Sciences. As a key member of our Regulatory Affairs department, you will be responsible for managing and delivering the CMC Dossier for our small molecule product in development.
Key Responsibilities:
- Provide CMC Regulatory support to the CMC Technical team in relation to EU requirements and international regulations.
- Compile regulatory documents in support of submission on time and in line with EU requirements.
- Identify rate limiting deliverables and interdependencies with other sections.
- Provide status updates to the Dossier authoring team and Submission manager as needed.
- Manage all documents through the document management system.
- Ensure that all documents are collected in due time and are e-CTD format compliant.
- Represent Regulatory CMC within the CMC development team and other transversal teams.
- Advise CMC members with regard to CMC regulatory requirements.
- Write or review the CMC documentation from the development teams.
- Organize the schedule of deliverables (sections of the dossier) with the development teams.
- Manage responses to questions from authorities.
Requirements:
- 8-10 years of experience in managing the delivery of late phase CMC Regulatory documents for EU submission and international regulations.
- Organized and independent with ability to manage multiple activities concomitantly.
- Degree in a relevant science/technical subject.
- English language proficiency (read, written, spoken).
- Taste of contacts and teamwork.
- Oral and written communication skills.
- Experience in project management is a plus.
