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.
Key Responsibilities:
Preferred Skills & Experience:
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