The CMC Regulatory Sciences Specialist position is responsible for providing Chemistry, Manufacturing, and Controls (CMC) submission writing and support across Regeneron’s sites.

Routine activities include dossier development for marketing applications, amendments, post approval variations, and other regulatory submissions.

As a CMC Regulatory Sciences Specialist, a typical day might include the following :

• Prepares global CMC documents and sections for a variety of clinical and commercial biopharmaceutical regulatory submissions, ensuring that all submissions are complete, accurate and meet relevant requirements.
• Manages and coordinates the authoring, review, and finalization of CMC documents, and responses to CMC-related inquiries from Regulatory agencies, in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.
• Works effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
• May review relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
• May proactively identify issues and contributes to the development of appropriate strategies to mitigate risk.
• May assist in preparation for meetings with global regulatory authorities.

This role may be for you if :

• Strong written and verbal communication skills.
• Critical thinking and problem-solving skills
• Ability to work independently or as part of a team.
• Ability to multi-task and work in a dynamic environment.
• Knowledge of relevant drug development regulations and guidelines (i.e., FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).

In order to be considered for this position, you must hold a BA / BS degree required, preferably in a scientific related field and

• Specialist : 2 years of relevant experience.
• Senior Specialist : 5 years of relevant experience.
• May consider experience in lieu of education; level decided upon completion of an interview process.
• Technical writing, manufacturing process development and process controls, and / or CMC regulatory experience is a plus.

Last updated : 2024-05-19