Sr Associate Regulatory Affairs

3 weeks ago

Oklahoma City, United States BioPharma Consulting JAD Group Full time

BioPharma Consulting JAD Group is seeking a talented Sr Associate Regulatory Affairs in Juncos, Puerto Rico. The Sr Associate Regulatory Affairs will support regulatory submissions, including INDs, NDAs, BLAs, and lifecycle management activities. They will collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.

Responsibilities: Reviewing and providing regulatory guidance for labeling and promotional materials Preparing and maintaining regulatory dossiers and documentation Assisting with regulatory inspections and audits Keeping up-to-date with regulatory guidelines and changes in regulations Contributing to continuous improvement initiatives within the Regulatory Affairs department Assist the RA CMC Site Regulatory team in supporting regulatory activities, including facility registrations, variations/supplements, and country-specific document coordination. Provide and maintain Clinical Trial Application (CTA) and Marketing Authorization (MA) documentation support, such as annual reports and amendments, in collaboration with the Site Regulatory Lead. Create and maintain product regulatory history documents, EPIC, and appropriately archive all regulatory documents and agency communications. Coordinate the collection of functional documents in support of regulatory applications. Support the preparation of regulatory documents and packages. Respond to specific requests from and communicate relevant issues to Site RA CMC management. Serve as a regulatory assessor in the CCMS/Nonconformance system for changes/events related to products manufactured at the site. Provide regulatory support to Commercial Operations, Process Development's New Product Introduction, and/or functional groups through cross-functional interactions within CMC. Assist in the development and maintenance of EPIC templates. Support the development and execution of RA CMC site goals.

Education: Master's degree or Bachelor's degree and 2 years of related experience in a pharmaceutical industry environment or Associate’s degree and 6 years of related experience in a pharmaceutical industry environment or High school diploma/GED and 8 years of related experience in a pharmaceutical industry environment. Preferred Qualifications: Experience with electronic document management systems Knowledge of regulatory requirements outside of the United States Ability to work well in a fast-paced, team-oriented environment Strong analytical and problem-solving skills

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