Demonstrating a good degree of competence in regulatory affairs and understanding of dossier technical requirements within the region, this role provides technical subject matter expertise to support Country RA teams with their local publishing and agency submission transmission needs.
Develop superior product and disease state knowledge and effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy, safety profiles to support on-label prescribing for appropriate patients.
Bachelors, Master degree or PhD in science, math, engineering or related discipline; The Principal, Regulatory Affairs, Intelligence, Materials is expected to perform with minimal supervision and is an experienced and detail-oriented professional with expertise in materials and with an understanding of the interplay of materials and medical devices, pharmaceuticals and combination products.
B. Pharm, B.Sc. for BA BE and For clinical B. Pharma or M.Sc. Or M.B.B.S.B. V. Sc. and A.H is compulsory. M. V. Sc. Pharmacology and Toxicology is desirable for preclinical; Check CROs for conducting preclinical/ clinical/ bio equivalence studies by site feasibility/ selection visits or evaluation for ensuring adequate facility, skill and experience for conducting the studies as per requirements
Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority, package insert, SmPC, PIL & MSDS preparation
Online applications in prescribed format from eligible candidates for filling up the vacant posts as per the table mentioned below at the approved Urban Health Center and Urban Health and Wellness Center at District Urban Health Unit Ahmedabad District under National Urban Health Mission under 11 months fixed salary contract. is summoned. According to which the applicant should apply on the website of Arogya Sathi (HRMS) the suitably qualified candidates dt. Online only with all the attested physical evidences by 5.00 PM on 29/06/2024.
Assists Head-Bioanalytical in the smooth running of the bioanalytical section through efficient project and quality management in conformance to GLP guidelines.