Job Description

We are seeking a Regulatory Affairs Manager or Regulatory Affairs Specialist with a strong background in oral solid dose pharmaceuticals and hands-on experience with CMC (Chemistry, Manufacturing & Controls) to support regulatory submissions and compliance activities. The ideal candidate will have direct experience authoring regulatory submissions, working with API and CMC change management , and have familiarity with scale-up activities . Candidates with exposure to Ad Promo, Pharmacovigilance, and stability requirements are a plus.

• No third party vendors
• Must be able to work onsite in TN
• Relocation available

Key Responsibilities:

• Support product lifecycle and post-approval activities through compilation, authoring, review, and submission of regulatory documents including:
• NDA/ANDA filings , amendments, supplements, annual reports, DMF updates, and labeling packages
• Ensure regulatory submissions comply with applicable FDA regulations and guidelines
• Participate in and manage regulatory aspects of change control review and approval
• Provide regulatory input on CMC-related issues and work closely with cross-functional teams (R&D, QA, QC, Manufacturing)
• Maintain regulatory compliance throughout the product lifecycle, including stability requirement oversight
• Collaborate on Ad Promo and Pharmacovigilance activities (as applicable)
• Manage submission timelines and support regulatory project planning
• Stay up-to-date on relevant FDA regulations and industry trends
• Other responsibilities as assigned by management
• Qualifications:
• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Microbiology, Premed, Nursing)
• Minimum of 2 years of regulatory affairs experience with RAC certification, or 4+ years of relevant pharmaceutical industry experience in a cGMP and/or FDA-regulated environment

Preferred Skills & Experience:

• Solid understanding of oral solid dose formulations , scale-up , API , and CMC changes
• Experience with FDA submissions and eCTD publishing
• Familiarity with Ad Promo submissions and labeling/marketing material review
• Knowledge of stability protocols and associated regulatory requirements
• Strong understanding of FDA regulations, guidance documents, and ICH requirements
• Excellent written and verbal communication skills

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