Regulatory Expert

Job Title: Regulatory Publishing Specialist – Veeva eCTDWe are seeking a skilled Regulatory Publishing Specialist to join our team. As a key member of our regulatory publishing group, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.Prepare and manage BLA (Biologics License Application)...

Regulatory Compliance ExpertThe ideal candidate will have expertise in both pharmaceutical and medical device regulatory compliance.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 regulatory requirements...

Job SummaryWe are seeking an experienced professional to lead our regulatory affairs in food export regulations across multiple markets. This role requires a deep understanding of international food laws and regulations, as well as the ability to monitor and analyze global regulatory updates.Key Responsibilities:Lead regulatory intelligence on domestic and...

Job Description:As a Senior Regulatory Affairs Specialist, you will be responsible for leading and managing CMC regulatory activities for USFDA submissions. This includes preparing, reviewing, and filing ANDA documents, as well as overseeing the compilation and submission of Annual Reports, amendments, and deficiency responses.Key Responsibilities:Manage and...

Compliance ProfessionalRole Overview:The Role: We seek a detail-oriented and proactive Compliance Specialist to join our team. This individual will play a critical role in ensuring our trading activities and internal practices comply with regulatory standards and internal policies.Key Responsibilities:Employee Trading Compliance: Conduct thorough reviews of...

Key Responsibilities:Lead and manage regulatory activities for US FDA submissions, including ANDA preparation, review, and filing.Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams to gather required documentation and data.Review and ensure compliance of Batch Manufacturing...

Job OverviewWe are seeking a seasoned quality expert to lead our quality assurance function and ensure compliance with industry standards, certifications, and regulatory requirements.Key ResponsibilitiesDevelop and implement effective quality management systems as per ISO 9000 and other applicable standards.Manage and renew necessary licenses and ensure...

Job Title: Financial Professional - Accounting and Taxation ExpertLocation: India (On-site/Hybrid)Reporting to: Senior Finance ManagerCertification Required: Chartered Accountant (ICAI, India) – MandatoryJob Overview:We are seeking a highly skilled accounting and taxation expert with Chartered Accountant (CA) certification from the Institute of Chartered...

The role of a Business Development Manager requires specialized knowledge in healthcare regulations and compliance.Key ResponsibilitiesGather, analyze, and document business requirements related to HIPAA, CMS, NCQA, and state-specific regulations. Ensure system changes, processes, and documentation remain compliant with these regulations.Act as liaison with...

Job Title: Financial ExpertThe primary role of this position is to provide financial guidance and ensure compliance with regulatory standards.Responsibilities:Conducting audits of financial statementsFiling tax returns for individuals and businessesPreparing balance sheets and profit/loss accountsEnsuring financial compliance with laws and...