CMC Regulatory Compliance Specialist

Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a detail-oriented professional to support end-to-end submissions for global markets.">Key Responsibilities:">">Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.">Contribute to Lifecycle Management (LCM) activities...

Job Overview:We are seeking a highly skilled Regulatory Publishing Specialist to join our team. In this role, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.Key Responsibilities:Compile and publish regulatory documents according to global health authority requirements.Ensure compliance with...

Key Responsibilities include Regulatory Monitoring & Implementation, Compliance Advisory & Governance, Reporting & Communication, Testing & Review, Audit & Inspection Management and Legal.This role involves tracking regulatory updates, assessing their impact on policies and business processes, and disseminating them to senior management for timely...

Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs professional to lead our pharmaceutical and medical device regulatory compliance efforts.Developed, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications, ensuring timely and compliant...

Leading our team in Open Banking is a dynamic opportunity to work on the future of finance. Our role involves guiding and leading newly established teams, ensuring compliance with regulatory frameworks, and aligning strategic objectives with clients.The ideal candidate will have 10+ years of experience as a Business Analyst in a regulatory environment,...

Tax Compliance SpecialistKey Responsibilities:Verify tax logic within SAP S/4HANA and Ariba workflows to ensure accuracy and compliance.Review vendor exemptions, address verification, and multi-tax codes to guarantee adherence to regulatory requirements.Experience with Vertex Accelerator+ or OneSource setup is crucial for success in this role.Support...

Job Overview:The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He/ She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the...

Key Responsibilities:The Quality Assurance Compliance Specialist plays a pivotal role in ensuring regulatory compliance, quality system management and process improvements in sterile injectable manufacturing environments.Document Management: Prepare and review QMS-related documents, including SOPs, work instructions and templates for validation,...

Broking Operations SpecialistWe are seeking a seasoned Broking Operations Specialist to drive business growth by leveraging expertise in broking operations and regulatory compliance.Key Responsibilities:Audit Execution and Planning: Conduct comprehensive audits of broking activities to ensure adherence to regulatory requirements and industry...

Job Summary:The Compliance Officer plays a vital role in maintaining organizational compliance with regulatory requirements. This includes ensuring timely submissions to relevant authorities.Main Responsibilities:Conduct Anti-Money Laundering (AML) transaction monitoring to identify potential risks.Review customer Risk Categorization to ensure accurate...