779 Regulatory Guidelines Jobs - Page 15

As a candidate for the role, you will be responsible for supporting Citi's Third-Party Management Program. Your key tasks will involve implementing key processes, ensuring compliance with policies, and guiding internal stakeholders. Your role will include completing activities related to the Third Party lifecycle, ensuring data accuracy for reporting metrics, and mitigating associated risks in line with Citi's requirements for suppliers. Responsibilities: - Demonstrate strong knowledge of Third Party Lifecycle Management, Regulatory guidelines, Contract Terms & conditions, Information Security, and relevant regulations. - Provide process guidance and support to Third Party Officers (TPOs), B...

*QC Reviewer (Clinic):* 1) Review of clinical raw data as per predefined Quality Control Plan for completeness, accuracy, and for compliance with the Study Protocol, GCP, SOPs and applicable regulatory Guidelines. 2) Online Monitoring of study activities to ensure that studies are conducted in accordance with GCP, SOPs, Protocol and applicable regulatory guidelines. 3) Issuance, Reconciliation and Accountability of Controlled forms/ Documents as per applicable SOP. 4) Preparation of projects for QA audit and Archiving. 5) Review of Tabular listing appended to Clinical Study Report and Individual Subject CRF scan check (as applicable). 6) Assist QC in-charge in review of Quality Control- Clin...

As a Quality Control & Microbiology Department Manager, your role involves ensuring online documentation compliance with cGMP & GLP standards. You will be responsible for overseeing testing procedures, reviewing specifications, and approving necessary documentation. Your key responsibilities include: - Ensuring all testing is conducted according to approved specifications and standard procedures - Reviewing and approving specifications and test procedures for starting materials, in-process, and finished products - Checking and approving certificates of analysis for raw materials, in-process samples, packing materials, and finished products - Supervising online data recording during analytica...

Role Overview: As a Certified POSP Insurance Agent at Notion Insurance Broker, you will play a crucial role in advising clients and selling insurance policies. Your primary responsibilities will include understanding the insurance needs of clients, promoting and selling various insurance products, guiding clients through the policy selection process, maintaining regular communication with clients, and staying updated with product knowledge and regulatory guidelines. You will be supported by Notion's tech-driven platform and comprehensive product training. Key Responsibilities: - Understand clients" insurance requirements and recommend suitable policies. - Promote and sell various insurance p...

,in-processthe ,for leading,for leading,problem-solvingResponsibilities We are looking for a senior professional AGM with a range of 15 to 20 years of experience in Analytical Method Validation for regulated markets. The role involves leading API and excipient method validation across multiple dosage forms and managing a team of 30, including three senior managers. The ideal candidate must be technically strong, experienced in US/EU compliance, and hold an M. Pharm, M.Sc., or Ph.D. Role & responsibilities: Accountable to lead the team for AMV of OSD, Nasal, Injectables, Ophthalmic and Topical dosage formulations. Responsible for RM & PM characterization and documentation. Generate qualificat...

Position: Senior Regulatory Affairs Manager Global Cosmetics Compliance Department: Regulatory Affairs / Operations Reports to: COO (Integrator) & CEO Location: India, Noida- Sec- 63 Employment Type: Full-time Shift Time- 12 PM IST- 9 PM IST About CBAYEXPRESS / Herbishh: CBAYEXPRESS CORPORATION is a Canadian-based e-commerce company selling across Amazon (US, CA, MX, UK, EU, AU, SG, IN, UAE), Walmart, Shopify (Herbishh.com, BisonBody.com), eBay, and other marketplaces. Our flagship brand Herbishh is a leader in haircare and beauty, with rapid global expansion. With $15M+ annual revenue, we are scaling towards $30M+ globally, and compliance is a key pillar of our success. Role Overview: We ar...

What you become a part of: The IPQA Officer/Executive will be responsible for ensuring in-process quality assurance activities across all manufacturing operations. The role involves monitoring compliance with SOPs, GMP standards, and regulatory requirements, along with reviewing documentation and supporting process validation. What to expect: Monitor raw material dispensing activity. Perform daily IPQA activities as per SOP-defined frequency and ensure timely closure of IPQA observations. Conduct validation sampling as per approved validation protocols. Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and compliance. Perform ERP-related transactions of IPQA...

Execution Analyze the customer segmentation, sales trends in terms of demographics, geography, characteristics etc. to assess the potential for business Conduct trainings at the branch for all banking partners around regulatory guidelines and products. Plan for activation of branches through R&R activities to increase the penetration in active branches to realize full potential of the bank partner in the given geography Relationship Management Drive the campaign/contest for the Partner Bank to drive sales in profitable segments. Assist banking partners in pitching product to crucial customers & driving sales closure for the same. Identify cross sell opportunities for existing customers New A...

Cargill's size and scale allows us to make a positive impact in the world. Our purpose is to nourish the world in a safe, responsible and sustainable way. Cargill is a family company providing food, ingredients, agricultural solutions and industrial products that are vital for living. We connect farmers with markets so they can prosper. We connect customers with ingredients so they can make meals people love. And we connect families with daily essentials from eggs to edible oils, salt to skincare, feed to alternative fuel. Our 160,000 colleagues, operating in 70 countries, make essential products that touch billions of lives each day. Join us and reach your higher purpose at Cargill. This po...

Job Description: As an Insurance Sales Team Manager, you will lead, mentor, and motivate a team of 12-15 insurance sales representatives to achieve individual and team performance goals. Your responsibilities include driving the team towards meeting monthly, quarterly, and annual sales targets aligned with company objectives. Conducting regular training sessions on product knowledge, sales techniques, and compliance requirements is essential. Tracking and analyzing team performance metrics, providing feedback, and acting as a communication bridge between management and the team are key aspects of your role. Additionally, you will assist in building and maintaining strong client relationships...

As a Senior Principal Scientist in Peptides Purification at Piramal Pharma Solutions, your primary responsibility will be to lead, design, and execute advanced research projects focused on the purification of peptide molecules. Your key stakeholders will include internal teams such as Operations, Marketing, Quality, Finance, and Senior Leaders, as well as external stakeholders like Vendors and Customers on a need basis. You will report functionally to the Associate Director R&D. - Lead and manage peptide R&D Purification projects from inception to completion, ensuring timelines, budgets, and quality standards are met. - Design and implement advanced purification strategies for peptide molecu...

Role Overview: As a Senior Manager / Chief Manager - Underwriting at Tata AIG General Insurance Company Limited in Mumbai, you will play a crucial role in managing the underwriting profile for various departments such as Retail Health, Group Health, Travel, Extended Warranty, and Corporate. You will have the opportunity to contribute to the growth of these departments and be a part of one of the preferred private general insurance companies in India. Key Responsibilities: - Manage the underwriting profile for various departments, including data management and cuts on UW, FY basis - Review Various Product Portfolio Management and scrutiny of product proposals, risk analysis, and decision-maki...

Role Overview: As the Director of Market Risk Oversight within the Finance Risk Management Group in GRC, Market & Liquidity Risk at American Express, you will be responsible for providing strategic leadership and independent oversight for market risk management across American Express and American Express National Bank (AENB). Your role will involve developing and implementing market risk management strategies, policies, and procedures. Additionally, you will lead a team of risk professionals to ensure effective identification, assessment, and mitigation of market risks. Monitoring trends, market developments, and regulatory changes will be crucial in proactively identifying emerging risks a...

You are a strategic thinker passionate about driving solutions in Treasury.You have found the right team. As a Liquidity Associate in our Finance team, you will spend each day defining, refining and delivering set goals for our firm. You will be instrumental in managing the liquidity, balance sheet, and capital positions of our Investment Banking businesses. In this role, you will engage with a variety of stakeholders, including senior leadership and global teams, to develop and implement strategies that enhance our risk management capabilities. This position offers a dynamic and fast-paced environment, ideal for individuals with a keen interest in capital markets and economics. Job Responsi...

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,...