Concord Biotech Limited an Ahmedabad based Biotechnology company is hiring for Regulatory Affairs Officer position. There is total 1 vacancy so if you are the right one then do consider applying.
Job description
- Well versed with Compilation, review, amend and submission of Drug Master files to various regulatory authorities i.e. US, EUROPE, Canada & other countries as per schedule and customer requirements.
- Able to review and update CEP dossier for the submission to EDQM.
- Able to review queries of FDA, EDQM, regulated and non regulated markets.
- Know how to review and make necessary corrections in validation documents such as process validation, AMV of assay, related substance, residual solvents etc.
- Able to review and update TDP, STP of raw materials, finished products and packing material to support regulatory queries.
- Able to review the changes affected to the regulatory submission and to check the impact on the regulatory filling through change control document.
- Able to submit DMF in eCTD, Query response and other regulatory documents through various platforms such as ESG, CESP, EMA gateway etc.
- Review and submission of Life Cycle management of DMFs(Variations/Amendments/Annual Updation /Quin-Annual) as per schedule.
- To lead and provide guidance and trouble shooting of technical activities related to Quality control and quality assurance.
- Responsible for responding to the FDA and liaison with US and European regulatory authorities.
About Concord Biotech Limited
Concord Biotech Limited is an R&D based vertically integrated Biotechnology company having state-of-the-art manufacturing facility, offering fermentation, semi-synthetic APIs and Finished dosage forms. Concord practices cGMP and its API facility is been inspected & approved by Global Regulatory agencies like USFDA, EU-GMP, Japanese AFM, Local FDA, Korean FDA. From single block of Enzyme in 2000, now Concord has build up more than 20 dedicated API manufacturing blocks, having over 500 M3 fermentation capacity and commissioned separate facility for manufacturing Finished dosage forms. Concord has diversified portfolio of APIs in the area of Immunosuppressant, Oncology, Anti-bacterial, Anti-fungal, Animal Health, Enzyme, Statins and others. Concord also offers Contract Research & Manufacturing services of APIs in the area of fermentation & semi-synthetic molecules. On Finished dosage forms, Concord is initially focusing on solid orals, liquid orals & topicals of Immunosuppressant followed by solid oral dosage of Oncology and general product and future expansion in Specialty formulations.
Location of Company
1482-1486, Trasad Road, Dhollka Ahmedabad, Gujarat , Dholka, Gujarat, India
How To Apply?
You can apply for the post of Regulatory Affairs Officer at Concord Biotech Limited, Ahmedabad by using the below apply button.