Job Description

Job Description

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*Must be US Citizen

We are seeking a 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.

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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