A fast-growing pharmaceutical organization is seeking a Regulatory Associate or Senior Regulatory Associate. This key role supports the development and submission of regulatory documents to the FDA and other global health authorities. Responsibilities span new drug applications (NDAs and ANDAs), post-approval changes, regulatory lifecycle management, and ensuring cross-functional coordination and compliance. This team is looking for a detail-oriented professional with strong knowledge of FDA regulations and a collaborative, growth-oriented mindset. The ideal candidate is someone who thrives in a fast-paced environment, values accuracy, and brings a strong sense of ownership and adaptability.

Regulatory Associate Responsibilities: 

• Prepare, compile, and submit regulatory submissions including ANDAs, NDAs, BLAs, INDs, Bio-INDs, and ANADAs in eCTD format
• Perform technical evaluations to ensure submissions meet FDA regulatory standards
• Support post-approval lifecycle management, including labeling updates and submission of changes
• Track submission timelines and monitor regulatory authority feedback and requirements
• Collaborate cross-functionally with departments such as R&D, Quality, Legal, and Supply Chain to gather data
• Assist in drafting and submitting Annual Reports and PADERs
• Track and interpret FDA announcements, policy updates, and competitor regulatory activity
• Contribute to process improvements and maintenance of regulatory tracking systems

Regulatory Associate Requirements: 

• Bachelor’s degree in life sciences, pharmacy, or related field required
• 2–3 years of regulatory affairs experience in the pharmaceutical industry
• Strong understanding of FDA regulations and submission types (NDAs, ANDAs, INDs, post-approval)
• Hands-on experience preparing eCTD submissions using publishing tools
• Familiarity with labeling requirements, SPL formats, and drug listing procedures
• Ability to interpret technical documents and evolving regulatory guidance
• Knowledge of US and international regulatory environments
• Effective communicator, both written and verbal, across cross-functional teams

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