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:
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:
Preferred Skills & Experience:
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