| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Oil & Gas Jobs |
| Banking Jobs |
| Construction Jobs |
| Top Management Jobs |
| IT - Software Jobs |
| Medical Healthcare Jobs |
| Purchase / Logistics Jobs |
| Sales |
| Ajax Jobs |
| Designing Jobs |
| ASP .NET Jobs |
| Java Jobs |
| MySQL Jobs |
| Sap hr Jobs |
| Software Testing Jobs |
| Html Jobs |
| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Manufacturing |
| Functional Area | Operations Management / Process Analysis |
| EmploymentType | Full-time |
*Compilation and submission of Abbreviated New Drug Applications (ANDAs) in CTD format for US and other markets as per respective regulatory requirementsCompilation of responses pertaining to CMC, Dissolution, Bioequivalence, Microbiology and Labeling deficiencies and ensuring that registration approvals are granted without undue delayLabeling, SPL and drug listing activitiesReview and approval of submission related documents such as Batch Manufacturing Records, Packaging Records, Analytical Reports, Stability reports, Technology transfer documentsDrafting controlled correspondences to USFDADue diligence of products planned for acquisitionKnowledge-sharing with stakeholders like Plant, R&D on latest requirements of regulatory bodies aiming to achieve quality filings and product approval within the defined timelines (e.g. ANDA GDUFA goal dates)Identifying the appropriate filing category for post approval changes and submissions to USFDAPreparation of regulatory strategy documentsProviding regulatory costing for new projectsParticipation in site audit/inspection, when scheduledLifecycle management of approved products Data base management, *Minimum 8+ years of experience in Regulatory Affairs with primary focus in regulated markets for US, EU and Canada Well versed in ANDA filings, drafting deficiency responses and eCTD requirementsExpertise in submissions of various dosage forms with primary focus on OSDs and InjectablesHands-on experience in eCTD submissions (Compilation/ Publishing/ Drug Listing)Knowledge of current regulatory requirements and guidelinesStrong verbal and written communication skills
Keyskills :
formscontinuous improvement facilitationstrategywritten communicationctdrecordsregulatory affairsdraftingbatch manufacturingtechnology transferregulatory requirementssplandacostingfilingcmc