Manager CMC/CP Regulatory Affairs

2 weeks ago


Dublin, Ireland Regeneron Pharmaceuticals, Inc Full time

The candidate will support the development and execution of regulatory strategies for biologic products and combination products for the portfolio assigned and perform the duties outlined below

In this role, a typical day might include the following:


• Support CMC/Combination product development activities from a regulatory standpoint during early phase, development, submissions and post market requirements
• Participate in IOPS cross-functional meetings for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate or fix them, translates ambiguity into actional steps. Ensure appropriate communications between IOPS and global RA in a timely manner
• Review the content and format of regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements, scientific advice) to ensure compliance with applicable regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics
• Participate in global RA meetings and help to develop regulatory strategies to support CMC/CP activities. Participation in communications between Global RA and IOPS as needed

This role may be for you if have:

• Need to have good understanding of current CMC RA worldwide regulations
• Experience in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologic products / combination products
• Experience in dealings with FDA and other regulatory authorities is an advantage
 

To be considered for this opportunity we are looking for:

•Bachelor’s degree in a relevant technical, scientific field required; advanced degree is an advantage
•A minimum of 6 years (BS/BA) or 4 years (advanced degree) pharmaceutical/biotech proven experience including a 2 - 4 years of relevant CMC experience



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