This role involves authoring and reviewing submissions, assessing change controls, coordinating cross-functional teams, interacting with regulatory agencies, and guiding the regulatory affairs team
Job Summary
This role involves authoring and reviewing submissions, assessing change controls, coordinating cross-functional teams, interacting with regulatory agencies, and guiding the regulatory affairs team.
The position ensures high-quality, compliant submissions that support the company’s product portfolio.
Leading preparation and review of CMC sections for ANDAs, supplements, and amendments.
Matching Summary
This role involves authoring and reviewing submissions, assessing change controls, coordinating cross-functional teams, interacting with regulatory agencies, and guiding the regulatory affairs team.
Skills & Requirements
Must-have
CMC regulatory activities for ANDAs
authoring and reviewing submissions
evaluating change controls
coordinating cross-functional teams
interacting with regulatory agencies
Nice-to-have
promoting continuous improvement
knowledge sharing
mentoring and coaching
Key Requirements
Master’s degree in pharmacy, chemistry, pharmaceutical sciences, or related field
4-6 years of experience in regulatory affairs focusing on CMC
Proven experience in authoring, reviewing, and managing CMC sections
Strong knowledge of FDA and global regulatory requirements