515 Regulatory Guidelines Jobs - Page 8

As an experienced Quality Assurance (QA) professional with 8-10 years of experience in clinical research, pharmaceuticals, or life sciences, you will play a crucial role in ensuring the highest standards of quality and compliance at MSCR. Your expertise in ICH-GCP and GLP principles will be essential to maintain regulatory guidelines, clinical QA processes, and GLP compliance throughout the organization. Key Responsibilities: - Develop and maintain ICH/GCP-compliant processes to control the quality of work and clinical studies at MSCR. - Lead and manage internal quality audits, CAPA activities, and quality management reviews. - Conduct study audits to ensure adherence to sponsor protocols, G...

We are looking for a highly skilled Regulatory Medical Writer with 3 to 8 years of experience to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in the IT Service & Consulting industry. Roles and Responsibility Develop high-quality regulatory documents, including clinical trial applications, marketing authorizations, and other related submissions. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company standards. Conduct thorough research and analysis of regulatory guidelines, laws, and regulations to inform document content. Create clear, concise, and well-structured documents that meet regulatory requirements. Review an...

As a Scientist in this role, your primary responsibilities will include: - Executing experiments for analytical method development, qualification, and transfer - Conducting in-process and stability sample testing, biosimilarity analysis, and new high throughput formats of testing using chromatography (HPLC/UPLC), electrophoresis/capillary electrophoresis, UV spectrophotometer, Solo-VPE, and other high-end analytical tools - Analyzing samples in GC, Atomic absorption spectroscopy (AAS), Charged Aerosol Detector (CAD), and glycan analysis - Planning experiments sequentially and logically - Accurately recording experiment details in electronic laboratory notebook following good documentation pr...

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication

Company Name Funwave Foods Job Title Quality Chemist (Freshers) Job Location: Gujarat Description At Funwave, we believe that the potato farming model should be more than just a job opportunity. We want to create maximum value at every step of the value chain. Our approach is to produce best quality potatoes,ensuring our farmers are able to produce continuously with assured returns. We work on contract farming model for surety of quality production, continuity of Farmers with assured returns for them. Vacancies: 2 Positions Role Overview Conduct routine quality checks on raw materials, in-process, and finished products. Ensure compliance with food safety standards and regulatory guidelines. ...

Role Overview: As a Block Head at our injectable manufacturing facility, you will lead a key production block. Your main responsibilities will involve overseeing end-to-end manufacturing operations, managing a team of production staff, driving process optimization, ensuring regulatory audit readiness, maintaining compliance with cGMP standards, implementing changes, overseeing equipment and maintenance, coordinating cross-functionally, and managing inventory and resources. Key Responsibilities: - Oversee end-to-end manufacturing operations - Manage a team of production staff - Drive process optimization - Ensure regulatory audit readiness - Maintain compliance with cGMP standards - Implement...

As a Wealth Management Associate / Advisor in Trivandrum, Kerala, you will play a crucial role in managing and growing clients" investment portfolios to help them achieve their financial goals. Your responsibilities will include: - Assisting clients in managing their investment portfolios based on their financial goals and risk appetite - Providing personalized wealth management solutions including mutual funds, insurance, bonds, equities, and other financial products - Conducting periodic portfolio reviews and staying updated with market trends and regulatory guidelines - Collaborating with internal teams for client onboarding and compliance checks - Building and maintaining long-term clien...

As a member of the VTC MFG. QA team, your role will involve handling the Quality Management System (QMS) for drug substance of bacterial products. You are expected to have a strong understanding of the processes involved in both upstream and downstream unit operations. Your responsibilities will include: - Managing QMS documents including deviations, change controls, and investigations using Track-wise software. - Ensuring audit compliance and adherence to regulatory guidelines. - Proficiency in documentation tasks such as Standard Operating Procedure (SOP) development and Batch Manufacturing Record (BMR) preparation. Qualifications required for this role include: - A minimum of 3 to 6 years...

Role: Business Head Global Out-Licensing & Business Development Europe, Canada & Australia Location: Mumbai Summary of the Role: PSS has been mandated to hire a Business Head - International Markets for a growing, mid-sized branded generics pharmaceutical player (products in gastro-intestinal, rheumatology, orthopedics, cardiology, dermatology, and diabetes), that is looking for the right candidate to establish its EU business through distributors (to end customers in Europe) and to tap into possible contract manufacturing opportunities with EU pharmaceutical companies. The company has three state-of-the art plants in India. Its main plant in Himachal Pradesh has recently received an Europea...

Role Overview: As a Statistical Programmer at Statistics & Data Corporation (SDC), you will be responsible for providing statistical programming support for clinical trials. Your primary role will involve producing statistical analyses, generating and validating analysis datasets, tables, listings, and figures for clinical trials. You will be required to create SDTM mapping and datasets, develop and maintain project files of SAS datasets and SAS code, and support Data Management in various data-related tasks. Additionally, you will act as a liaison between clinical subcommittees and project teams as needed. Key Responsibilities: - Overseeing statistical programming activities for medium to l...

In this role as the Feasibility Lead in Clinical Trials, your main responsibility will be managing and delivering comprehensive feasibility assessments for early-phase clinical trials. This involves ensuring the scientific, operational, and regulatory viability of proposed sites and countries, as well as collaborating with internal stakeholders and external clients to support proposal development. Key Responsibilities: - Lead feasibility planning and execution to support project bids and early engagement efforts. - Drive data-driven site and country selection strategies and serve as a subject matter expert in feasibility best practices. - Provide strategic input on protocol design, country, ...

Role & responsibilities - The Deputy/Assistant Registrar (Academics) will be responsible for overseeing the academic administration of the university, ensuring adherence to regulatory guidelines, maintaining quality standards, and supporting the implementation of effective teaching-learning practices. The role will require close collaboration with faculty, academic leaders, and regulatory bodies to strengthen academic processes and uphold excellence in education delivery. Preferred candidate profile - The Deputy/Assistant Registrar (Academics) will be responsible for overseeing the academic administration of the university, ensuring adherence to regulatory guidelines, maintaining quality sta...

As the Utility Systems Manager in injectable facilities, your primary role will involve overseeing operations, ensuring compliance with regulations, and implementing efficient facility management practices. You will lead the execution of greenfield/brownfield injectable facility projects, from design to qualification, including tasks like budgeting, procurement, construction, and commissioning. Your responsibilities will also include overseeing critical utility systems like WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems to ensure smooth operation and compliance with standards. Key Responsibilities: - Manage greenfield/brownfield facility projects from start ...

Role Overview: The Shift Chemist at Pharma Manufacturing department is responsible for achieving the desired production yield of pharmaceutical APIs by ensuring all production activities in the shift comply with cGMP, cGLP, EHS requirements, and specified operating procedures. You will be required to properly take over shift operations as per defined procedures. This includes following the Gowning Procedure before entering the pharma area, indenting raw materials from stores, updating balance in Material Reconciliation Record, collecting Intermediate material, ensuring availability of Utilities before charging the batch, verifying and charging raw material quantities, executing production pr...

As a Client Relationship Executive at Jainam Broking Limited in Bhavnagar, your primary role will involve building and nurturing long-term relationships with clients. You will focus on understanding their financial requirements, risk tolerance, and investment objectives to ensure high levels of client satisfaction and retention. By recommending appropriate stock market products and services, you will provide valuable financial advice to clients. Your responsibilities will include: - Addressing client queries and resolving issues through various communication channels like phone, email, or chat. - Assisting clients in opening Demat and trading accounts to facilitate a smooth onboarding proces...

As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, your role will involve running the department independently. You should possess strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Managing and ...

Role Overview: You will be working as an Executive - QC in the Small Molecule Bioanalytical Research Laboratory at Syngene International Ltd. in Bangalore, India. Your main responsibility will be to review data for BA/BE studies in the laboratory, including checking method development, validation, and sample analysis data. You will report to the Head / Group Leader of the Small Molecule Bioanalytical Laboratory. Key Responsibilities: - Perform data checks (QC) for method development, validation, and study sample analysis. - Review STPs, Protocols, validation, and bioanalytical reports. - Ensure necessary documents and records are updated and ready for audits (Sponsor / Regulatory). - Handle ...

a. Should have experience in the development of Solid Oral Dosage forms for general and potent products. b. Should be well versed with various regulatory guidelines. c. Should have through knowledge about fundamentals of pharmaceutical development. d. Good communication skills are must. Development of Solid Oral Dosage forms for general and potent products

Role Overview: You will be responsible for reviewing internal audit reports to ensure consistency and uniformity across various audit areas. Under the supervision of the Team Leader and guidance of the Group Head, you will undertake activities to maintain the effectiveness of the Internal Audit function. Key Responsibilities: - Conduct quality checks (QCs) on audit reports to ensure consistency and uniformity across different audit areas - Propose and conduct ad hoc reviews to achieve consistency and coverage of audits, highlighting areas for improvement - Assist the team leader in preparing notes for the Board and Audit committee presentations - Support the team leader in creating the quart...

As the Chemical and Instrumental Testing Analyst at Sun Pharmaceutical Industries Ltd, your role involves conducting testing on samples of raw materials to ensure the quality of products manufactured for both domestic and emerging markets. Your responsibilities include: - Conducting Chemical and Instrumental testing on samples of raw materials - Implementing system upgrades in alignment with CQ and regulatory guidelines - Analyzing and reporting stability and finished goods samples when necessary - Monitoring gowning and sanitation practices within the operational area - Ensuring compliance with standard operating procedures for analytical instrument operation - Operating analytical equipmen...

Role Overview: You will be responsible for regulatory reporting in Mumbai, India. Your role will involve preparing and checking various regulatory reports to be filed with Central Bank, SEBI, Income Tax, FIU, etc. in a timely manner. Additionally, you will need to provide adhoc requirements sought by regulators promptly. You will also be expected to provide clarifications to regulatory queries related to inward and outward transactions filed with Central Bank. Interacting with various departments of Deutsche Bank to collate data required for regulatory filings and providing data to auditors will be part of your responsibilities. Knowledge and experience in Cash Products would be preferable f...

NOTE- This job requires you to work from Capgemini Office(Pan India). JOB DESCRIPTION The Senior Statistician collaborates with Biostatisticians, Statistical Programmers, Clinical Data Managers, Clinical Research Associates, and sponsors teams to provide high-quality, reliable statistical expertise and support. Additionally. they perform and oversee quality control (QC) of data displays with inferential statistics. Also, Senior Statistician conduct QC analysis datasets prepared by others, maintain project administration files (including protocols, annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications), QUALIFICATIONS FOR...

Role Overview: As a member of the Corporate Quality Control department in the Pharmaceutical & Life Sciences industry, your primary responsibility will be to perform the analysis of raw materials, intermediates, and finished products of Active Pharmaceutical Ingredients (APIs). You will operate and maintain analytical instruments like HPLC, GC, UV-Vis Spectrophotometer, FTIR, Karl Fischer, Melting Point Apparatus, among others. Key Responsibilities: - Perform analysis of raw materials, intermediates, and finished products of APIs according to approved specifications and SOPs. - Review and verify analytical data, ensuring proper documentation in compliance with cGMP and GLP guidelines. - Prep...

Role Overview: 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. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. - Critically reviewing documentation intended for s...

Role Overview: As the Application Lead at Compressed Bio Gas (CBG) manufacturing sites, you will be responsible for overseeing and enhancing enterprise applications that support the operations and business functions. Your role involves managing applications such as LIMS, remote monitoring interfaces, and custom applications to ensure reliable performance and stakeholder satisfaction. Working closely with cross-functional teams, you will lead solution design and drive IT-enabled process improvements. Key Responsibilities: - Lead the end-to-end application lifecycle management, ensuring smooth operation and performance of business-critical applications. - Act as the primary point of contact fo...