2122 Regulatory Affairs Jobs - Page 36

We are looking for a skilled Operations Analyst to join our Account Processing Unit team at Equitas Small Finance Bank. The ideal candidate will have 1 to 4 years of experience in the BFSI industry, with expertise in liability operations and account processing. Roles and Responsibility Manage and process accounts accurately and efficiently. Analyze and resolve account-related issues promptly. Collaborate with internal teams to ensure seamless operations. Develop and implement process improvements to boost productivity. Maintain high customer satisfaction through excellent service. Ensure compliance with regulatory requirements and company policies. Job Requirements Strong understanding of li...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also ...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP S/4HANA for Product Compliance Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your day will involve overseeing the application development process and ensuring successful implementation of solutions. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform....

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices a...

We are looking for a highly skilled and experienced Operations Analyst to join our team at Equitas Small Finance Bank in the BFSI industry. The ideal candidate will have 2 to 7 years of experience in liability operations, deliverables, or related fields. Roles and Responsibility Manage and analyze operational data to identify trends and areas for improvement. Develop and implement process improvements to increase efficiency and reduce costs. Collaborate with cross-functional teams to achieve business objectives. Prepare and present reports to senior management on operational performance. Identify and mitigate risks associated with operational activities. Ensure compliance with regulatory req...

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 2-3 years of experience in the BFSI industry, preferably with a background in risk management or a related field. Roles and Responsibility Conduct thorough analysis of customer data to identify potential risks and develop strategies to mitigate them. Collaborate with cross-functional teams to implement effective risk management plans and monitor their progress. Develop and maintain relationships with key stakeholders, including customers, vendors, and internal teams. Identify and assess new business opportunities and provide recommendations for ...

We are looking for a highly skilled and experienced Legal Receivable Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 3-4 years of experience in the BFSI industry, preferably with a background in Inclusive Banking - SBL, Mortgages, or Legal Receivables. Roles and Responsibility Manage and oversee legal receivables, ensuring timely recovery of outstanding amounts. Develop and implement effective strategies to minimize legal receivables and improve cash flow. Collaborate with cross-functional teams to resolve customer disputes and issues related to legal receivables. Analyze and report on legal receivables performance metrics, providing insights for improve...

Role & responsibilities Architect and implement a lean, auditready ISO13485:2016 Quality Management System and drive certification. Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Define and execute regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives. Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records. Train cross...

Back office Executive -AGRI-FIN-TRACTOR LOANS AND RETAIL(TFE)-Recovery Grade E0 Role- Back Office Executive : Manage the documentation post credit analysis of the region Responsible for management of day to day operations of the region. Ensuring strict adherence to compliance, audit and regulatory requirements. Timely authorization and checking KYC system input for customer transaction/ service request Good at MS Office Customer complains management and ensuring resolution of all complaints within TAT. Job Requirements: Excellent written and oral communication skills Graduate Minimum work exp. 2 years Customer service oriented People Management skills Good communication abilities

Job Summary: We are seeking a dynamic and strategic Senior Product Manager in TPP team. This role demands end-to-end ownership of product performance, including P&L accountability, regulatory compliance, stakeholder management, and innovation. The ideal candidate will be a proactive leader with a deep understanding of the insurance landscape and a proven ability to drive revenue through cross-functional collaboration. Key Responsibilities: Product P&L Ownership: Take full responsibility for the product lines profitability, including pricing strategy, cost management, and performance tracking. Revenue Growth: Drive top-line growth by collaborating with distribution channels (digital, agency, ...

Functional Responsibility Having sound knowledge of banking domain (Wholesale, retail, core banking, trade finance) In-depth understanding of RBI Regulatory reporting and guidelines including RBI ADF approach document. Should have experience in handling various important regulatory returns like Form- A, Form VIII (SLR), Form X, BSR, SFR (Maintenance of CRR) ,DSB Returns, Forex, Priority sector lending related returns to RBI Should have an understanding of balance sheet and P&L. Supporting clients by providing user manuals, trainings, conducting workshops and preparing case studies. Process Adherence Review the initial and ongoing development of product Responsible for documenting, validating...

Role & responsibilities Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timel...

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The business is structured into two key segments: Specialty Pharmaceuticals and Generics & APIs. In the Specialty Pharmaceuticals segment, the company specializes in Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. The Generics & APIs segment focuses on Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma, with Research & Development units located in Noida and Mysore, India. JGL operates manufacturing facilit...

You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Your tasks will include reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. It is essential to critically review documentation intended for su...

You will be working at Jubilant Pharma Limited, a global integrated pharmaceutical company that offers a wide range of products and services across different geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. JGL operates manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing. The Mysore manufacturing site, spread over 69 acres, is USFDA approved and manufactures APIs targeting Lifestyle driven Therapeutic Areas such as CVS and CNS. The Roorkee fac...

As the DM- Regulatory Affairs at Olympus Medical Systems India Private Limited, your primary responsibility will be to oversee Indian regulatory affairs activities related to Gastrointestinal (GI) & Olympus products. You will also be responsible for advising and consulting with stakeholders about compliance with CDSCO, BIS, WPC, and other applicable regulatory bodies. Your role will involve implementing best practices and contributing to both the strategic and operational functions of the regulatory affairs team. Your key responsibilities will include assessing regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. You will evaluate the reg...

The Global Safety Officer (GSO) for Marketed Products plays a crucial role in ensuring the safety and well-being of the assigned marketed products. As a GSO, you will be responsible for establishing the strategy, direction, and priorities of pharmacovigilance activities related to the assigned products. Your accountability extends to overseeing the overall safety profile, making product-related decisions, and delivering on all associated responsibilities. Leading the Safety Analysis Team (SAT), Global Safety Team (GST), and serving as a core member of the Executive Safety Committee (ESC), you will be an integral part of the safety governance structure. Additionally, as a member of the Eviden...

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration and device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Health insurance Annual bonus Office cab/shuttle Provident fund

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation/Post Graduate Diploma in Finance/Bachelors degree with Finance specialization Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.co...

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation/Post Graduate Diploma in Finance/Bachelors degree with Finance specialization Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.co...

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation/Post Graduate Diploma in Finance/Bachelors degree with Finance specialization Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.co...

In this role you will work with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), Global Submission Teams and Local Operating Company regulatory contacts to deliver End to End submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs (Standards Operating Procedures) and working practices. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Accountable to the Global Regulatory Lead and Global Regulatory staff for the delivery of lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Au...

1. Lead the implementation of Prisma Cloud security solutions for securing containerized applications, focussing on runtime protection, vulnerability scanning, compliance monitoring and network security 2. Design and architect secure container environments using Prisma cloud to protect container registries, Kubernetes clusters & microservices 3. Configure and manage Prisma Kubernetes security to monitor and enforce security policies in Kubernetes clusters, focusing on threats like misconfigurations, network vulnerabilities and un-authorized access. 4. Integrate Prisma security products into continuous integration pipeline to automatically scan container images, manage vulnerabilities. 5. Con...

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must hav...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory