Description: Our client is currently seeking a Regulatory Project Manager
This job will have the following responsibilities:
Provide regulatory and CMC support related to the design and implementation of strategies with US and international clients for the development of new drugs and/or combination products (drug/drug or drug/device).
Write or review documents, as applicable, and compile regulatory dossiers for submission to FDA and/or global health authorities, including IND, NDA, BLA, ANDA, DMF, supplement, IMPD, etc. Provide regulatory guidance and submission strategy to clients based on FDA/EU/ICH guidelines or other regulatory agency guidance requirements. Interpret and apply regulations as they apply to specific project issues, including assessment of application changes requiring supplements/amendments.
Project Management: manage multiple assigned projects and proactively communicate with project teams/clients; coordinate/discuss project specifics; establish timelines for submissions.
Work with and learn from senior-level regulatory professionals. Work with document management and publishing teams on project deliverables.
Qualifications & Requirements:
Employment experience in Regulatory Affairs is a must, including knowledge of eCTD submissions, understanding of the processes for health authorities interactions, interpretation, and applications of regulations (21 CFR, FDA, ICH).
Experience in a consulting environment is a plus.
Requires a BS/BA in Regulatory Sciences or Life Sciences. RAC and/or MS/Ph.D. are a plus.
Prior experience with eDRLS submissions is a plus.
All candidates must possess a strong attention-to-detail, and be able to organize and multitask, with teamwork, and verbal/written communication skills.
Contact: arawat@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
