Drug Regulatory affairs, handling team size of 50 plus including executives, sr. executives, asst. managers. Meetings with Client, FDA/MOH officials. Experienced with Appointment 2000 plus applications & approvals across the world for drug registration, Queries, variations, post approval compliances etc.

Leading DRA team of 30 plus. CTD, ACTD, BE, CT, CMC, PSUR, SPC, ROW countries. More than 500 registrations/ DRC across the world.

drug regulatory affairs, handled team size of 15 plus including executives, Sr. executives.

1. Dossier compilation and preparation as per ACTD, CTD and Regional format for various formulations like ORAL- Tablets, Capsules, Granules, Syrups, Suspension, TOPICAL- Ointment, Paste, Lotions, Creams, Gel, INJECTIONS and Ophthalmic etc. for Following countries: Latin American countries- Guatemala, Costa Rica, Panama, Venezuela & Honduras, El Salvador. Asian pacific countries –Myanmar, Vietnam, Cambodia, Hong Kong, Philippines, Sri Lanka CIS countries- Ukraine, Kazakhstan, Uzbekistan, Kyrgyzstan, Belarus, Armenia, Moldova, Tajikistan, Turkmenistan, Georgia Mongolia and Russia. African countries- Togo, Benin, Ivory cost, Cameroon. 2. Drafting of administrative documents for the issuance of FSC, COPP, FORM 25, 28, 26, GMP.3. Work experience on Regulatory software like ZOHO PROJECTS, MANAGE ART WORK, JOT FORM, COLLAVATE and PHARMASUITE etc. for preparation, compilation, review, checking, submission, handling of NOD/queries and maintenance of regulatory documents. 4. Preparation and Compilation of Quality Documents Like Pharmaceutical Development Report, BMR, BPR, Stability Protocol & Report, Process Validation Protocol & Report (PV), Certificate Of Analysis. Specifications, STPs, Art works, SPC, package inserts.5. Preparation of periodic safety update report (PSUR).6. Review of Analytical Method validation Protocol & Report (AMV), DMF.7. To Co-ordination with QA/QC & Research and development team to carry out validation programs.8. Collecting required Pharmacology/Toxicology/Clinical data through literature & internet review for preparation of Module 4, Module 5 Summary of Product Characteristics (SPC) for different products and package inserts (PI).9. Resolution of NOD (Notice of Deficiencies) raised by Regulatory Authorities.10. Handling DCGI, FDA related work like BE for Export Permission application filling, COPP, Documentation and various responsibilities assigned time to time, Verification of files before submission.

dossier compilation for latin and CIS countries. CMC ,Clinical and Non clinical documents review, Queries reply, variation application etc.

• Preparation of Dossiers for new drug approval (form 44) , BE for export applications.• Critical review, checking of bioequivalence protocols and BE reports. • Critical review & submission of Toxicity reports.• Critical review & PSUR preparation for DCGI submission.• Critical review, checking of clinical trial protocols and Clinical trial reports.• Preparation of therapeutic rationale and justification for fixed dose combinations.• Preparation BE waive off justification, Clinical trial waive off justification.• Critical review & Preparation of executive summary & for NDAC presentation• Dealing with DCGI for Import registration of Raw Materials, New Drug Application submission

Preparation and Compilation of Quality Documents Like BMR, BPR etc.