515 Regulatory Guidelines Jobs - Page 5

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

Responsibilities: Lead and oversee the entire Quality Control department operations. Ensure compliance with cGMP, regulatory guidelines, and company quality standards. Review and approve analytical methods, specifications, and validation protocols. Supervise raw material, in-process, and finished product testing. Ensure timely release of batches and materials. Manage laboratory investigations, OOS, OOT, deviations, and CAPA. Coordinate with QA, Production, and Regulatory teams for smooth operations. Handle audits (internal, external, and regulatory) and ensure readiness at all times. Provide training, mentoring, and performance evaluation of QC staff. Drive continuous improvement, cost effic...

Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations. Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements. Regulatory Compliance & Communication Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines. Review and submit annual reports, amendments, variations, and renewals as required. Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner. Documentation & Data Collec...

Responsibilities: Documentation & Record Review: Review specifications, sampling instructions, test methods, and analytical reports. Review and approval of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR), and Equipment Qualification Records. Review completed Batch Production Records and Laboratory Control Records post-batch completion. Review analytical data, Calibration & Preventive Maintenance schedules, and external audit reports. Review and finalize Certificate of Analysis (CoA) for finished products. Review Draft Equipment Cleaning Records and Hold Time Study protocols/reports. Review Standard Operating Procedures (SOPs) and Annual Product Quali...

Job Title: Compliance Executive (Female) Location: Gujarat Experience: 02 years (Basic knowledge in compliance) Job Type: Full-time Job Description: We are looking for a diligent and detail-oriented Compliance Executive to support our compliance team. The ideal candidate should have basic knowledge of compliance processes, regulatory requirements, and be eager to learn and grow in the field. Key Responsibilities: Assist in ensuring the organization complies with internal policies and external regulations. Support documentation and record-keeping for compliance-related activities. Assist in preparing reports and maintaining trackers for regulatory submissions. Help coordinate with internal te...

As an intern at Vivimed Labs Limited, you will have the opportunity to be involved in various day-to-day responsibilities, which include: - Ensure compliance with GMP and regulatory guidelines. - Assist in documentation and record-keeping activities. - Support day-to-day operations across multiple departments such as QA, QC, MIS, production, sourcing, and packaging. - Conduct quality checks and maintain process standards. - Learn about pharmaceutical manufacturing processes and best practices. - Maintain logs, reports, and necessary documentation. - Adhere to safety and operational protocols in all tasks. - Collaborate with cross-functional teams to ensure efficiency. - Gain equal opportunit...

Role Overview: As an Associate Manager / Manager in API Regulatory Affairs - DMF Filing/ Compilation for the global market, your responsibilities will include: - Hands-on experience in Regulatory Affairs-API/DMF Filing/DMF Compilation/ Submission/ Customer Communication. - Compiling and submitting DMFs globally for small molecule APIs in eCTD format, ensuring compliance with ICH and region-specific regulatory guidelines (EU, US, Canada, Japan, Australia, Brazil, China, South Korea, etc.). - Demonstrating good knowledge of all regulatory guidelines and API Regulatory processes. - Compiling responses to queries from Regulatory Agencies & customers globally, meeting specified timelines for subm...

As an experienced individual with 5+ years of aircraft maintenance experience, including 1-5 years of certifying experience, your role will involve various responsibilities and qualifications, including: Role Overview: - Inspect and certify maintenance activities for aircraft systems to ensure airworthiness. - Ensure all maintenance work complies with OEM and DGCA standards for quality and safety. - Maintain and complete accurate maintenance records and logs for future reference. - Address and rectify defects identified during inspections or reported by crew members promptly. - Ensure the safe use of tools and equipment during servicing to prevent accidents. - Use only approved materials and...

Role Overview: As a Senior Specialist in Treasury Operations-IBFX, your primary responsibility will be processing Treasury FX and Merchant transactions, focusing on Interbank FX transactions. It is crucial to ensure that all transactions comply with regulations and internal SOPs before validation. Your expertise in Forex, regulatory guidelines, deal validations, settlements, deal confirmations, and CCIL reporting will be vital for the efficient performance of your duties. Key Responsibilities: - Validate all FX products (such as CTS, Forwards, Loans, and deposits) by ensuring that all pre-deal requirements are met before processing. - Process settlements for client transactions, including pr...

Position Overview Job Title: Reference Data Analyst, NCT Location: Bangalore, India Role Description The project involves verification of the Client data, performing due diligence checks on the Clients, reviewing KYC documentation performing the risk assessment of the Client, liaising with the Business/Compliance, advising on KYC requirements and signing off on new client adoptions. The Reg & Tax analyst role is an operations function where you will be involved in reviewing various regulatory documents related to clients to ensure that all the regulatory requirements are met and the bank is in compliance. What We'll Offer You As part of our flexible scheme, here are just some of the benefits...

As a QC Assistant at Devdort located in GIDC Naroda, Ahmedabad, you will play a crucial role in ensuring the quality control processes are carried out effectively. Your primary responsibilities will include: - Conducting quality control tests using advanced lab equipment such as HPLC, polarimeter, pH conductivity, and other relevant tools. - Ensuring compliance with Good Laboratory Practice (GLP) and industry standards. - Documenting test results meticulously and maintaining accurate records. - Assisting in audits and regulatory inspections to uphold quality standards. To excel in this role, you should possess a BSc/MSc in Chemistry and have 4 to 5 years of relevant experience. Additionally,...

Vihaas Design Technologies is a leading R&D tech company in Himachal, with over 8 years of innovation and recognition as one of the fastest-growing firms in the HimachalTricity region. As part of the company's expansion to Tricity, there are exciting opportunities available for the new Mohali office. You will play a crucial role in leading the design and development of digital and analogue electronics for telecommunications products, from initial concept through to production. Your responsibilities will include developing sensor systems, conducting simulations, preparing comprehensive design specifications, and driving validation and verification activities. Additionally, you will ensure tha...

Job Description: As a Medical-Regulatory Writer Assistant Manager, your main responsibility will be to plan and manage Medico-Regulatory Writing in accordance with relevant Regulatory Guidelines. You will be expected to deliver high-quality medical and scientific writing, provide technical consultation and advice on strategy and regulations, demonstrate subject matter expertise, effectively manage writing projects to meet deadlines, collaborate with internal and external clients, and produce various types of reports including CTD Modules, Safety Reports, and Aggregate Reports. Key Responsibilities: - Conduct science reviews of aggregate reports - Ensure document compliance with client specif...

Execution Support partners to register claims on behalf of customers, coordinate to ensure approvals within agreed timelines. Engage with cross functional teams to ensure seamless execution of work across channels and deliver desired productivity including everyday servicing and policy issuance etc. Gather relevant documents from customer post sales and submit the same to operations team; gather additional data/documents as required Resolve operational issues faced by the partners to ensure smooth experience while working with Bajaj General Insurance Limited Provide support for cancellation requests, policy endorsements; process & track such requests in coordination with internal ops team ; ...

Execution Support partners to register claims on behalf of customers, coordinate to ensure approvals within agreed timelines. Engage with cross functional teams to ensure seamless execution of work across channels and deliver desired productivity including everyday servicing and policy issuance etc. Gather relevant documents from customer post sales and submit the same to operations team; gather additional data/documents as required Resolve operational issues faced by the partners to ensure smooth experience while working with Bajaj General Insurance Limited Provide support for cancellation requests, policy endorsements; process & track such requests in coordination with internal ops team ; ...

As a Project Manager focused on EPR compliance, consulting & assurance Projects at The Kabadiwala, your role involves managing all aspects of project management related to Plastic waste management, E-waste management, Tyre waste & Battery waste for Large FMCG, MNCs, and Consumer product manufacturing companies. Your key responsibilities include: - Managing all aspects of project management under EPR compliance for various projects - Maintaining relationships with Central and state pollution control board officials - Taking responsibility for successful fulfilment of brands EPR target and timely reporting - Setting and achieving EPR targets to generate revenue across all geographies/locations...

Position Overview Job Title: KYC Associate Location: Jaipur, India Role Description The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the bank's clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating procedures (SOP's) and Operati...

Roles and Responsibilities Review documents from various departments to compile regulatory submission. Oversee drug master file for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMF s to ensure regulatory complience. Coordinate with CFT to address deficiency and feedback from RA and customers. Conduct CFT meetings to ensure timely responses to regulatory deficencies and customer inquires. Provide regulatory guidance to product development teams and attend technology transfer meetings to support compliance. Respond promptly to technical queries from regulatory bodies and customers.

Role & responsibilities 1. Regulatory Submissions & Approvals Prepare, compile, review, and submit dossiers (CTD/eCTD/ACTD formats) for product registration. Handle drug master files (DMFs), ANDAs, NDAs, INDs and ensure timely submissions to health authorities. Manage variations, renewals, amendments, and post-approval changes . 2. Compliance & Regulatory Guidance Ensure products comply with national and international regulatory guidelines (FDA, EMA, DCGI, CDSCO, WHO, ICH, etc.). Monitor regulatory changes and updates and communicate implications to management. Provide regulatory strategy and support to R&D, QA, QC, and manufacturing teams. 3. Documentation & Records Review and maintain CMC ...

JOB PURPOSE: Understanding and supporting in implementation and monitoring of the regulatory/statutory guidelines across the organization. FUNCTIONAL RESPONSIBILITIES: Monitoring RBI guidelines on an ongoing basis, intimating process owners on the requirements, clarifying dept/process owner queries, implementation of directions in coordination with process owners, ensuring compliance within timelines. Review of new proposals, new partner tie ups, process or policy change requests submitted by stakeholders and advise/guide the team on the compliance aspects. Preparing and reviewing of policy documents for compliance function Advising the Board and committees of the Board on RBI compliances an...

Role & responsibilities Understanding and supporting in implementation and monitoring of the regulatory/statutory guidelines across the organization. Monitoring RBI guidelines on an ongoing basis, intimating process owners on the requirements, clarifying dept/process owner queries, implementation of directions in coordination with process owners, ensuring compliance within timelines. Review of new proposals, new partner tie ups, process or policy change requests submitted by stakeholders and advise/guide the team on the compliance aspects. Preparing and reviewing of policy documents for compliance function Advising the Board and committees of the Board on RBI compliances and preparing applic...

Responsibilities: * Collaborate with cross-functional teams for documents and dossier compilation * Ensure compliance with regulatory guidelines & standards * Documentation. calibration, validation,....

**Job Description:** As a Senior Fund Administrator fluent in French with a background in finance or banking, you will play a crucial role in the high-performing financial operations team based in McKinley Hill, Taguig. Your responsibilities will include managing significant financial transactions, guaranteeing account accuracy, and collaborating with various teams to enhance operational workflows. **Key Responsibilities:** - Process and reconcile financial transactions meticulously - Manage intricate and sensitive account portfolios - Maintain precise records and ensure readiness for audits - Address discrepancies and escalate exceptions when necessary - Collaborate with internal and extern...

As a highly experienced and motivated individual, you will be leading the Analytical Development Laboratory (ADL) team in the Research & Development (R&D) division. Your role will involve developing analytical methods for various dosage forms, managing the ADL team, collaborating with cross-functional teams, ensuring proper documentation, and optimizing processes for efficiency. **Key Responsibilities:** - Lead the development of analytical methods for various dosage forms such as oral solids, oral liquids, topical dosage forms, capsules, etc. - Manage, guide, and lead the ADL team to achieve departmental objectives and ensure high-quality work standards. - Collaborate with cross-functional ...

As a Program Management Intermediate Analyst at Citi, your role will involve executing day-to-day activities to support Citis Third Party Management Program. You will be responsible for implementing key, standardized processes related to compliance with Citis policies and standards, guiding internal stakeholders, monitoring the timely completion of Pre-Contract due diligence and post-contract ongoing monitoring activities, and ensuring data accuracy for reporting of third-party related metrics. **Key Responsibilities:** - Facilitate Citi businesses" ongoing compliance with Third Party Management requirements outlined in Citi policies and standards. - Provide process guidance and support to T...