We currently have a job opening for Executive Regulatory Affairs for Company that may interest you for Ahmedabad. Below is a summary of the position.
Designation : Executive Regulatory Affairs
Job Description:
? Dossier Preparation as per ACTD guidelines
? Technical Documentation / Dossier Review
? Managing, planning and delivering product registration relatede submissions for ROW markets as well as regulated markets.
? Assisting Marketing / NPD in queries related dealing with product development from concept phase to commercialization.
? Reviewing and Managing applications for Loan license, WHO-GMP, COPP and FSC
? Review of formulation dossiers and technical data received from R&D, QC and QA.
? Review & preparation of technical documents and providing inputs for their necessary revisions, corrections to smoothen the drug registration process.
? Handling technical / administrative queries pertaining to regulatory submissions and responding them on time.
? Review of various agreements including CDA, registration/ licensing/ supply/ agreement
Desired Candidate Profile: B.Pharm (Fresher) , Proficient in English, Computer Literate
If you believe you're qualified for this position and are currently in the job market or interested in making a change, please give me a call on +91- 9033026011 or Mail your resume on resume@rkhrm.com
Designation : Executive Regulatory Affairs
Job Description:
? Dossier Preparation as per ACTD guidelines
? Technical Documentation / Dossier Review
? Managing, planning and delivering product registration relatede submissions for ROW markets as well as regulated markets.
? Assisting Marketing / NPD in queries related dealing with product development from concept phase to commercialization.
? Reviewing and Managing applications for Loan license, WHO-GMP, COPP and FSC
? Review of formulation dossiers and technical data received from R&D, QC and QA.
? Review & preparation of technical documents and providing inputs for their necessary revisions, corrections to smoothen the drug registration process.
? Handling technical / administrative queries pertaining to regulatory submissions and responding them on time.
? Review of various agreements including CDA, registration/ licensing/ supply/ agreement
Desired Candidate Profile: B.Pharm (Fresher) , Proficient in English, Computer Literate
If you believe you're qualified for this position and are currently in the job market or interested in making a change, please give me a call on +91- 9033026011 or Mail your resume on resume@rkhrm.com
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