Regulatory CMC Consultant

About the Role:

We are seeking a highly skilled Regulatory CMC Consultant to join our team at Ividata Life Sciences. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the successful submission of our small molecule product in development to the EU and first line international countries.

Key Responsibilities:

• Manage and deliver the CMC Dossier (relevant section of Modules 1, Module 2.3 and Module 3) for the initial submission in EU & the first line international countries.
• Provide CMC Regulatory support to the CMC Technical team in relation to the EU requirements & the requirements for the first line international countries.
• 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 Dossier authoring team and Submission manager as needed.
• Manage responses to questions from the authorities.

Requirements:

• 8 - 10 years of experience in managing the delivery of late phase CMC Regulatory documents for EU submission and the first line international countries.
• Organized and independent with ability to manage multiple activities concomitantly.
• Degree in a relevant science/technical subject.
• English: read, written, spoken.
• Taste of contacts and teamwork.
• Oral and written communication skills.
• Experience in project management is a plus.