zydus We are recruiting for API Regulatory Affairs at Zydus API Park, Vadodara
Regulatory Affairs (API)
Designation: Senior Executive / Assistant Manager
QUALIFICATION: MSC, M Pharm, B Pharmacy and / or P.G Diploma in regulatory affairs with 3-9 years of experience in regulatory affairs (API).
The job requires preparation and submission of drug master files and certificate of suitability application (CEP) for Active Pharmaceutical Ingredients for submission to USFDA. European, and Rest of the World Regulatory Authorities using predefined checklists.
Candidates should draft regulatory write up for various sections like process description. validation, stability protocols and reports with special emphasis on regulatory ramifications. Should also review master documents and should possess regulatory skills i.e., impact assessment on cross linked sections and data.
They must have an experience and should possess the skills in eCTD, should track the timelines and report the hiccups to group leader on time. The job also requires to effectively communicate with customers by providing open part DMF, technical package,
query response to ensure the product registration across the world and to ensure starting material specifications as per ICHQ11 requirement.
Qualification: MSC M Pharm, B Pharmacy and / or P.G Diploma in regulatory affairs
Experience: 9-13 years of experience in regulatory affairs (API). Candidates are required to prepare and review high-quality Drug Master File and certificate of suitability application (CEP) for Active Pharmaceutical Ingredients for submission to USFDA, European, and Rest of the World Regulatory Authorities as per current regulatory requirement.
The job requires to file amendments and deficiency response within timelines with a go getter approach, to review documents related to DMF submission against predefined checklists and submission to various agencies globally. Candidates should keep all the regulatory database up to date.
They must possess ‘do it right the first-time approach’ with proven track record, should keep themselves up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Candidates should have good communication skills, email etiquettes and must have received first class throughout their academic carrier, should be energetic, determined to be successful, and will be able to deal with new or difficult situations easily.
Interested candidates can share their CVs with firstname.lastname@example.org