Senior Regulatory Reporting Specialist

Job Overview:A key role within our organization is available for a Senior Regulatory Affairs Specialist who will lead and manage CMC regulatory activities for USFDA submissions.Key Responsibilities:The selected candidate will oversee compilation and submission of Annual Reports, amendments, and deficiency responses.They will interface with cross-functional...

Job Title: Compliance OfficerThis role involves ensuring adherence to regulatory requirements, providing compliance guidance, and managing audits and inspections.The ideal candidate will have strong expertise in regulatory compliance, risk management, and legal matters. Continuously track and evaluate regulatory updates relevant to the organization. Assess...

Job SummaryWe are seeking a highly skilled Chartered Accountant to join our team. The ideal candidate will possess excellent analytical and problem-solving skills, with the ability to prepare financial reports and analysis for management.Key ResponsibilitiesPrepare detailed monthly financial reports and analysis for senior managementEnsure compliance with...

Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. The successful candidate will have strong knowledge of quality systems and regulatory frameworks for medical devices.About the Role:This position requires ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.The role...

Regulatory Affairs SpecialistJob Summary:The Regulatory Affairs Specialist will be responsible for managing initial submissions, variations, and full Lifecycle Management (LCM) deliverables for global markets. The ideal candidate will have a strong understanding of regulatory guidelines and experience with Veeva Vault RIM.Key Responsibilities:Prepare...

Key Responsibilities of Regulatory Affairs Specialist:Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.Ensured compliance with international, federal, and local regulations across pharmaceuticals and medical devices.Interacted with regulatory authorities (FDA, EMA,...

Regulatory Monitoring ExpertWe are seeking a skilled Regulatory Monitoring Expert to leverage Artificial Intelligence (AI), Natural Language Processing (NLP), and advanced analytics to automatically monitor, interpret, and analyze regulatory updates across multiple jurisdictions.Responsibilities:Continuously monitor global and regional regulatory bodies for...

Job Overview:We are seeking an experienced Regulatory Affairs Specialist to lead and manage CMC regulatory activities for USFDA submissions.Develop and implement regulatory strategies to ensure compliance with USFDA regulations, including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency...

Senior Accounting Specialist Job SummaryAs a Senior Accounting Specialist, you will be responsible for managing the day-to-day accounting operations. This includes overseeing accounts payable and receivable processes, preparing financial reports, and maintaining accurate records.Key Responsibilities:End-to-end accounting knowledge and experience is...

Job DescriptionWe are seeking a seasoned professional to lead our compliance function. The ideal candidate will be a qualified Company Secretary (CS) with a minimum of 10 years of experience in compliance and corporate governance, adheres to all statutory, regulatory, and internal governance standards.This role requires exceptional leadership, analytical,...