Regulatory Compliance Manager
1 week ago
Regulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, Veeva Vault RIMJob Responsibility: Prepare, compile, and review eCTD dossiers for submissions (e.G., ANDA/NDA /MAA/ANDS).Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements.Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent.Ensure completeness and technical accuracy of eCTD sequences.Troubleshoot validation issues before final submission.Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes).Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA/IB/II).Collaborate with internal departments to gather data and draft scientifically sound responses.Stay updated with changes in FDA, EMA, and ICH guidelines.Maintain regulatory databases, submission trackers, and approval records.Participate in audits and support regulatory inspections.Required Qualification & Skills: Bachelor's / Master’s degree in Pharmacy or related field. 1.5 – 2 years of relevant experience in Regulatory Affairs for regulated markets (Health Canada/US/EU)In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks.Strong understanding of dossier structure, eCTD publishing, and submission timelines.
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Compliance Program Manager
5 days ago
Odhav, India Equirus Full timeQualification: Graduation/ CA / MBACompany Secretary will be preferred but non mandatory.Experience: Minimum 4 + years of relevant experienceExperience in PMS compliance / AIF Compliance / Gift AIF and Distribution compliance will be preferred.Role Details: Ability to liaise and interact with regulators.Ability to manage Audits.Ensuring 100% compliance...
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Odhav, India IMS People Possible Full timeJob Title: Compliance Officer / Senior Compliance OfficerLocation: Makarba, Ahmedabad.Shift Timings:12:30 PM – 10:00 PM IST1:30 PM – 11:00 PM IST (During Daylight Saving Time)About the Role:We are looking for a detail-oriented and proactive Compliance Officer / Senior Compliance Officer to join our compliance team. The role involves managing and ensuring...
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Finance & Compliance Manager
1 week ago
Odhav, India GTPL Hathway Ltd. Full timeCompany's Website:- www.Gtpl.NetJob Title: Finance ControllerLocation: Corporate Office, AhmedabadReports To: Chief Financial OfficerRole OverviewThe Finance Controller will be responsible for overseeing all financial and accounting operations of the company, ensuring strong internal controls, statutory compliance, accurate financial reporting, and effective...
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Regulatory Affairs Specialist
1 week ago
Odhav, India BKM Health Pvt Ltd Full timeJob Responsibility: Prepare, compile, and review eCTD dossiers for submissions (e.G., ANDA/NDA /MAA/ANDS).Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements.Compile and validate submissions using tools...
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Quality Systems
1 week ago
Odhav, India Biotech Healthcare Full timeRole Objective:A key objective of this position is to design, implement and enhance organizational work practices that align with quality management principles. Role will focus on establishing a culture of continuous improvement, compliance and operational excellence within the organization. Role involves the development and maintenance of a Quality...
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Tax Compliance Manager
7 days ago
Odhav, India Anderson Global Full timeAnderson Global( https://anderson-global.Com/) is an educational based leading provider of corporate services, supporting entrepreneurs and investors across key markets including the UAE (Dubai), India, Singapore, France, Switzerland, the USA, and the Cayman Islands. With over 800 professionals and a strong acquisition track record, we deliver expert...
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Australian Superannuation Compliance Officer
1 week ago
Odhav, India CountHQ Full timeJOB DESCRIPTIONJOB TITLE : SMSF AccountantLOCATION : Ahmedabad, Gujarat, IndiaTIMINGS : 7:30 AM to 4:30 PMType : Full-time workRoles and ResponsibilitiesProviding specialist SMSF accounting and administration in accordance with regulatory and legislative requirements.The ability to work with minimal guidance on basic compliance jobs.Proactive approach for...
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General Manager
2 weeks ago
Odhav, India Biotech Healthcare Full timeRole ObjectiveA key objective of this position is to ensure adherence to global regulatory standards and best practices while maintaining robust quality systems. The role focuses on implementing effective quality processes, driving continuous improvement initiatives, and fostering a strong culture of compliance to guarantee the safety, efficacy, and quality...
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Assistant General Manager Quality Control
1 week ago
Odhav, India Biotech Healthcare Full timeRole ObjectiveA key objective of this position is to serve as a strategic leader by providing scientific, technical, and managerial expertise in Quality Control (QC) and Analytical Development across diverse product portfolios. The position is responsible for establishing, validating, and implementing robust analytical testing methodologies in alignment with...
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Management Accountant
1 day ago
Odhav, India IMS People Possible Full timeJob Description : Shift timing: 03:30 AM to 01:00 PM In day light saving : 04:30 AM to 01:30 PM Job Description:Division : IMS Decimal Key Responsibilities Monthly Management Accounts: Prepare and analyze monthly management reports for clients, ensuring timely, accurate, and compliant financial reporting.Bookkeeping: Maintain accurate and current financial...