Head Regulatory Affairs

Job Description : Head -Regulatory Affairs -API – Looking for a Well Recognized Professional from API -Pharmaceuticals Background for Drug Regulatory Affairs Should have Handled Onsite/Off Site Regulatory Audits. Experience in formulating the Most Effective Regulatory Strategies with an Ultimate Objective of Smooth & Quick Regulatory Approvals in Various Regions like, US, Europe & Japan & to Integrate those Requirements into QA/QC/Process/Product Development. Responsibilities Coordinate at all Stages from Technology Transfer, Regulatory Submissions, Subsequent Updates & Variations, Audits, Approvals, Commercialization & filing Variation for Post Approval Changes. Heading API Regulatory Dept. Responsible for DMF filling Across US, Europe & ROW. Responsible for life Cycle Management Activity of Same. formulate & lead Global CMC Regulatory Strategy for Development Projects or Marketed Products Authoring high-Quality CMC Documentation. Review & Oversee formulation of CMC Templates/Procedures. Monitor the Quality of Work by the team & Support Quality Improvement Initiatives as Appropriate. Conducting Periodic Regulatory Compliance Audits to ensure Regulatory Compliance. Provide Regulatory Evaluation & Providing on Time & of High Quality Advice (e.g. Change Controls for Marketed Drug Substance).. Qualification & Exp. MSc /PhD with About 20 -25 years of Exp. in Regulatory Affairs . 5 + years Leadership Experience as a “Head Regulatory Affairs API Specialties: Pharmaceutical Regulatory Affairs (API) Compliance Activities with respect to Regulatory Affairs Direct liaison with USFDA, EDQM, EU GMP Auditors as Regulatory Affairs Personnel

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