United States, CMC Regulatory Consultant RA_HC_13180-MZ
ProClinical is seeking a Senior Scientific & Regulatory Manager for a global, commercial stage biotechnology company based in Massachusetts. As a Senior Scientific & Regulatory Manager, you will be responsible for producing and editing CMC regulatory documents for submission to regulatory agencies located world-wide with emphasis on the FDA and EMA. Must have the ability to summarize technical study reports and subject matter expert provided data in a manner that supports the strategic intent of the regulatory submission. You will provide regulatory and research expertise for several projects and ensure successful preparation of high-quality submission-ready documents through effective implementation of team-based writing processes. You will work closely with all CMC related SMEs (Manufacturing of drug substance and drug product, labelling, process development and quality control). As a partner to subject matter experts ensure accurate and timely completion/delivery of information and review of regulatory submissions.
The ideal candidate has well-developed and demonstrable writing skills, understands strategic communications, and has the ability to "simplify the complex". Strategic/critical thinking skills, as well as initiative, are a must for this role! Additional skills needed include a sense of urgency (milestone/timeline driven) and the ability to ask questions and probe further.
Support all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs and NDAs/MAAs and track regulatory commitments.
Skills and Requirements:
A full job description is available on request.
Please visit our website at www.proclinical.com