
Senior Compliance Specialist
6 days ago
Key Responsibilities:
- Main duties include overseeing CMC regulatory activities for USFDA submissions such as ANDA preparation, review and filing.
- Lead compilation and submission of Annual Reports, amendments, and deficiency responses.
- Collaborate with cross-functional teams including Quality Assurance, Production, and R&D to gather necessary documentation and data.
- Review compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
- Coordinate with manufacturing units to ensure product and process alignment with regulatory requirements.
- Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.
Requirements:
- 7–10 years of experience in Regulatory Affairs – CMC with USFDA filings especially ANDAs.
- Familiarity with ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
- Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
- Exposure to quality systems, BMR review, and interacting with production/plant teams.
- Able to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.
-
Regulatory Compliance Professional
18 hours ago
Bareilly, Uttar Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Job Role: Compliance Specialist The organization seeks a seasoned Compliance Specialist to ensure adherence to regulatory requirements and governance processes. This individual will be responsible for monitoring and implementing regulatory changes, providing compliance guidance to senior leadership, and managing audits and inspections. Key...
-
Senior Compliance Officer
22 hours ago
Bareilly, Uttar Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000Job Title:A Senior Compliance Officer is required to lead and manage KYC operations in alignment with compliance frameworks, policies, and internal control standards.This individual will oversee Business-As-Usual (BAU) and client refresh processes while identifying opportunities for global process migration and scalability.The successful candidate will...
-
Compliance Specialist
3 days ago
Bareilly, Uttar Pradesh, India beBeeTax Full time ₹ 10,64,000 - ₹ 15,46,000Indirect Tax Compliance SpecialistJob Overview:This role involves validating tax logic in complex financial workflows to ensure regulatory compliance.The ideal candidate will review vendor exemptions, address accuracy, and multi-tax codes to guarantee adherence to regulations.Experience with setup and configuration of Vertex Accelerator+ or OneSource is...
-
Senior Security Compliance Manager
3 days ago
Bareilly, Uttar Pradesh, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000Job OverviewThis role involves leading a team of Regional Compliance Specialists, overseeing the security compliance program for physical security officer services at data centers. Responsibilities include ensuring all sites meet internal standards and external regulatory requirements.Key ResponsibilitiesRecruit, supervise, and mentor Regional Compliance...
-
US Business Compliance Specialist
22 hours ago
Bareilly, Uttar Pradesh, India beBeeBusinessCompliance Full time US$ 90,000 - US$ 1,10,000Job DescriptionWe are seeking a highly skilled Business Compliance Specialist to join our team in the USA. As a key member of our compliance team, you will be responsible for assisting clients with business formation and registration processes, ensuring timely completion and filing of annual reports, franchise taxes, and other recurring compliance...
-
Senior Compliance Specialist
17 hours ago
Bareilly, Uttar Pradesh, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 18,00,000Compliance Manager PositionThe primary role of this position is to oversee all Microsoft partner-related compliance activities, ensuring the company meets all required standards and internal policies.This involves developing and enforcing internal guidelines consistent with Microsoft's partner code of conduct, as well as staying up-to-date on Microsoft...
-
Senior Taxation Specialist
1 hour ago
Bareilly, Uttar Pradesh, India beBeeTaxation Full time ₹ 32,00,000 - ₹ 45,00,000Senior Taxation SpecialistWe are seeking a highly skilled and experienced Senior Taxation Specialist to join our team. As a key member of our direct tax department, you will be responsible for providing expert advice on tax matters to clients.Responsibilities:Tax Compliance: Ensure accurate and timely compliance with all tax laws and regulations, including...
-
Global Trade Compliance Specialist
2 days ago
Bareilly, Uttar Pradesh, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 15,00,000Global Trade Compliance Specialist Role:We are seeking a skilled specialist to join our team in the field of global trade compliance.Key Responsibilities:Perform Customs Trade HTS & ECCN Classification determinations for spare parts and other products for import and export purposes.Assist in collecting and maintaining accurate compliance data records.Support...
-
Strategic Compliance Specialist
1 hour ago
Bareilly, Uttar Pradesh, India beBeeGlobal Full time ₹ 1,00,00,000 - ₹ 1,50,00,000As a Global Compliance Specialist, you will play a pivotal role in spearheading our efforts to eradicate corruption and promote fair trade practices within the maritime sector.About the RoleThis exciting opportunity combines strategic leadership with hands-on project delivery, providing an chance to make a meaningful impact on the industry.Key...
-
Effective Compliance Specialist
7 hours ago
Bareilly, Uttar Pradesh, India beBeeCompliance Full time ₹ 20,000 - ₹ 25,000About Our Compliance Role">We are seeking a skilled Compliance Executive to join our team. This is an exciting opportunity for someone with a strong background in compliance monitoring and regulatory standards.">As a Compliance Executive, you will play a key role in ensuring effective compliance monitoring across residential child care homes in the UK. You...