Salary $85K-$100K
Relocation Candidates will be considered
Position Summary:
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