As an experienced EHS Engineer, you will be responsible for various key tasks including conducting HAZOP, Safety Risk assessment, and PSSR. You will also be involved in safety inspections, external audits, and ensuring compliance with regulations. Your role will encompass the implementation of Process Safety Management (PSM) elements, conducting IMS Audits, and maintaining necessary documentation. Workplace monitoring and organizing EHS trainings will be crucial aspects of your responsibilities. Moreover, you will be expected to adhere to company procedures and policies related to EHS, actively participate in Safety Committee meetings, organize fire drills and mock drills, and ensure the proper maintenance of Emergency Safety Equipments. Incident investigation, root cause analysis, and overseeing the Permit to Work system will be essential components of your role. Conducting Job Safety Analysis, identifying and rectifying unsafe conditions and acts will also be part of your duties. To qualify for this position, you should hold a B.Tech in Chemical Engineering and possess a minimum of 5 to 7 years of relevant experience in the field. Your expertise in EHS practices, regulations, and standards will be crucial in ensuring a safe and compliant work environment.,
Role Overview: As an Associate Manager / Manager in API Regulatory Affairs - DMF Filing/ Compilation for the global market, your responsibilities will include: - Hands-on experience in Regulatory Affairs-API/DMF Filing/DMF Compilation/ Submission/ Customer Communication. - Compiling and submitting DMFs globally for small molecule APIs in eCTD format, ensuring compliance with ICH and region-specific regulatory guidelines (EU, US, Canada, Japan, Australia, Brazil, China, South Korea, etc.). - Demonstrating good knowledge of all regulatory guidelines and API Regulatory processes. - Compiling responses to queries from Regulatory Agencies & customers globally, meeting specified timelines for submission. - Reviewing and submitting new DMFs, deficiency responses, amendments, and updates to various regulatory agencies. - Evaluating change controls and updating agencies by considering change categories. - Having hands-on experience in eCTD software. Qualification Required: - M.Sc. / M.Pharma degree. - Experience in Regulatory Affairs ranging from 11 to 18 years. Additional Details: If you possess the relevant experience for this role, please share your CV with rashmi.gupta@biocon.com including the following details: - Total Experience - Current CTC - Total number of DMF filings - Major markets handled globally - Notice Period - Willingness to work in Bangalore (onsite) for a 5-day work week.,