International Erosion Control Association
Regulatory Affairs Specialist
International Erosion Control Association, Bristol, Tennessee, us, 37621
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.
No Visas
Must be US Citizen
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
#J-18808-Ljbffr
No Visas
Must be US Citizen
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
#J-18808-Ljbffr