Executive

Job Description

Coordinate and Oversee Biocompatibility Animal Studies : Managebiocompatibility testing and animal studies for new RD products. Liaison between Labs andRD : Serve as the main communication link between labs and theRD team to conduct biocompatibility and animal studies. Strategy Development :Develop and execute strategies for biological assessments of both new andexisting products for regulatory submissions. Vendor Management :Handle vendor selection for biocompatibility, animal studies, and bioanalyticallabs, including negotiations and scope definition. Review Compliance Documents :Review study plans, reports, and amendments to ensure adherence to regulatoryrequirements. Biological Evaluation Plans :Prepare and review biological evaluation plans and reports in line withregulatory guidelines. Data Compilation for RegulatorySubmissions : Compile data from non-clinical studies for submissionsto regulatory bodies (DCGI, CE, and USFDA). Non -Clinical Study Justifications : Preparejustifications and rationales for non-clinical studies of RD products. Regulatory Query Compliance : Addressqueries raised by regulatory bodies. Cost Negotiation :Negotiate lab costs to ensure cost-effectiveness and justifications for studyprices. PR Process for Non-Clinical Studies :Initiate the PR process for non-clinical studies. Budget Management : Managebudgeting and obtain study approval. Identify New Labs : Find new certified labs fornon-clinical studies to ensure cost-effectiveness, quality, and timelycompletion. Team Development : Developand train the team to execute non-clinical studies for new RD products. Preclinical Research Articles : Prepareresearch articles detailing preclinical studies utilizing animal models. Requirements Experience: 2-5 yrs. of experience of toxicology, zoology, immunology or pharmaceuticalindustry Education: M.Sc. Toxicology, MSc. Biotechnology, MSc. Zoology, B.Pharma, M.Pharm orrelated field. Skills: Strongreading, writing and communication skills. Knowledge: Familiarity with regulatory requirements and guidelines(e.g., ICH, FDA, EMA). Experience with clinical trial protocols and data. Software Proficiency: Competency in Microsoft OfficeSuite (Word, Excel, PowerPoint) and familiarity with reference management tools(e.g., Pub Med, Elsevier) and document management systems. Communication: Excellent verbal and written communication skills. Abilityto work effectively in a team and independently. Organization: Strong organizational and time-management skills with theability to handle multiple priorities and meet deadlines.