Regulatory Affairs Specialist

Key Responsibilities

• Author, compile, review, and submit regulatory documents in eCTD format, including NDAs, ANDAs, DMFs, and post-approval submissions.
• Support FDA regulatory activities for marketed pharmaceutical products.
• Evaluate CMC regulatory impact of manufacturing and process changes.
• Develop regulatory strategies for post-approval changes and provide guidance to cross-functional teams.
• Prepare and review product labeling updates.
• Review regulatory documentation for completeness, accuracy, and compliance.
• Maintain regulatory databases and electronic document management systems.
• Monitor current FDA and international regulatory guidelines to ensure ongoing compliance.
• Support change control activities and regulatory documentation.
• Provide mentorship and guidance to junior regulatory professionals.
• Participate in project meetings and collaborate with Quality, Manufacturing, Technical Operations, and other functional groups.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• 5+ years of Regulatory Affairs experience within the pharmaceutical industry.
• Experience preparing and submitting eCTD regulatory filings.
• Strong understanding of FDA regulations and CMC regulatory requirements.
• Experience supporting post-approval changes for commercial pharmaceutical products.
• Ability to manage multiple projects in a fast-paced GMP environment.
• Strong written and verbal communication skills.
• Experience working cross-functionally and leading regulatory initiatives.
• Proficiency with Microsoft Office and Adobe Acrobat.
• Experience with electronic document management systems and change control software.
• RAC certification is a plus.