
Senior Regulatory Compliance Manager
1 week ago
Key Responsibilities:
- Oversee Regulatory Compliance: Manage CMC submissions, including ANDA preparation and filing.
- Evaluate Regulatory Accuracy: Review Batch Manufacturing Records, process validation documents, and site data for compliance.
- Collaborate with Cross-Functional Teams: Interface with Quality Assurance, Production, and R&D to gather documentation and data.
- Stay Up-to-Date on Regulations: Maintain knowledge of evolving USFDA guidelines and provide strategic guidance.
Required Skills and Qualifications:
- Regulatory Affairs Experience: 7–10 years of hands-on experience with USFDA filings (especially ANDAs).
- Regulatory Knowledge: Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
- Technical Document Preparation: Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
Benefits:
- End-to-End Submission Lifecycle: Ability to handle submission lifecycle, including post-approval changes and correspondence with the FDA.
- Quality Systems and BMR Review: Exposure to quality systems, BMR review, and interacting with production/plant teams.
-
Director of Regulatory Compliance
6 days ago
Shimoga, Karnataka, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000We are seeking a seasoned Associate Director to partner with business, operations, and regulatory teams.The role will focus on ensuring speed, compliance, and integrity in a highly dynamic regulatory environment.Key Responsibilities• Advise business teams on mobility laws, licensing, permits, and aggregator regulations across India.• Draft, review, and...
-
Senior Regulatory Advisor
6 days ago
Shimoga, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Job Description:We are seeking a seasoned professional to assume a senior role within our Financial Regulatory Practice. As Assistant Vice President, you will be responsible for leading complex client engagements across regulatory supervision, policy formulation, risk management, and compliance transformation.The ideal candidate will bring exceptional...
-
Regulatory Compliance Specialist
1 day ago
Shimoga, Karnataka, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 15,00,000Job Title:Compliance Assurance Officer (Regulatory) We are seeking a skilled professional to fill a Compliance Assurance Officer (Regulatory) position. This role is critical in ensuring adherence to regulatory requirements and maintaining the highest standards of integrity within our organization.Key responsibilities include:Reviewing and analyzing system...
-
Senior Regulatory Compliance Specialist
5 days ago
Shimoga, Karnataka, India beBeeRegulatory Full time ₹ 1,80,00,000 - ₹ 2,50,00,000Job Title:Principal/Subject Matter Expert-Regulatory ReportingKey Responsibilities:Lead complex change projects in financial and regulatory reporting, delivering continuous process improvements through technology and non-technology solutions.Independently manage implementation engagements with leading banks, financial institutions, NBFCs, insurance...
-
Compliance Officer Manager
6 days ago
Shimoga, Karnataka, India beBeeCompliance Full time ₹ 5,89,000 - ₹ 12,34,567Job Title:Compliance Officer ManagerAbout This RoleThe Compliance Officer Manager is a critical position responsible for ensuring adherence to regulatory and statutory requirements. This includes timely submission of returns, monitoring transactions for potential risks, categorizing customers based on their risk level, conducting regular reviews of various...
-
Compliance Professional
6 days ago
Shimoga, Karnataka, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 25,00,000Job opening for a Compliance Officer role in the financial industry.Key Responsibilities:Continuously track and evaluate regulatory updates relevant to the organization.Assess the impact of regulatory changes on policies and business processes.Disseminate updates to senior management and ensure timely implementation.Regulatory Compliance & GovernanceEnsure...
-
Compliance Specialist
3 days ago
Shimoga, Karnataka, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 28,00,000Compliance Officer">">">Job Description">We are seeking an experienced and highly skilled Compliance Officer to oversee all compliance functions, with a strong focus on governance, risk management, and regulatory filings.">Key Responsibilities">">Corporate Governance & Board Support: Advise the board of directors on all matters of corporate governance,...
-
Senior Compliance Specialist
6 days ago
Shimoga, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Job Overview:Corporate Counsel RoleWe are seeking a seasoned Corporate Counsel with 8-14 years of relevant experience in legal and compliance roles. The ideal candidate will possess expertise in corporate compliance programs, guiding the organization on complex regulatory matters.Main ResponsibilitiesMonitor risk and compliance issues, implementing...
-
Global Food Compliance Expert
3 days ago
Shimoga, Karnataka, India beBeeRegulatory Full time ₹ 1,80,00,000 - ₹ 2,00,00,000Senior Food Regulatory Manager PositionWe are seeking a seasoned Senior Food Regulatory Manager with profound expertise in international food regulations to assume a key role in our organisation.Lead regulatory intelligence on domestic and export food labelling regulations across multiple markets (EU, US, UK, GCC, Canada, APAC, SE Asia, Latin...
-
Senior Compliance Officer
5 days ago
Shimoga, Karnataka, India beBeeCompliance Full time US$ 1,80,000 - US$ 2,50,000Job TitleWe are seeking a seasoned legal professional to fill the role of Senior Compliance Officer.This key position will involve working closely with experienced members of the legal team to provide expert advice and solutions to business stakeholders.The successful candidate will possess a strong understanding of corporate compliance programs, including...