170 Regulatory Documentation Jobs - Page 5

Role & responsibilities The responsibilities of the role include processing Individual Case Safety Reports (ICSRs) and conducting literature screening activities. The candidate will be responsible for reviewing and assessing the validity of literature abstracts and articles, with further processing into the safety database as required. Additionally, the role involves maintaining the Extended Eudravigilance Medical Product Dictionary (XEVMPD) and performing EVWEB updates, including revisions to the Summary of Product Characteristics (SPC/SmPC) and Patient Information Leaflets (PILs). The candidate will also perform comparative reviews of SmPC and PIL documents against reference products. A ke...

Role & responsibilities We are seeking a Pharmacovigilance Associate with 2 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in processing Individual Case Safety Reports (ICSRs) and performing literature screening to identify safety information. This includes assessing validity of literature abstracts/articles for database entry. The role also involves maintaining XEVMPD, performing EVWEB updates, revising SmPCs, PILs, and preparing Risk Management Plans (RMPs). Monitoring safety updates/signals and ensuring SOP & regulatory compliance is essential. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, EVWEB Updates, SmPC ...

As a Compliance Officer at ParaaCrypto, you will play a crucial role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will include acting as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. You will be responsible for ensuring compliance with Indias VDA regulations and global best practices, updating internal SOPs, and maintaining regulatory documentation. Additionally, you will collaborate with legal, tech, and operations teams on compliance escalations. To excel in this role, you should have at least 5 years of experience in compliance, p...

Conduct NPD, process optimization, scale-up & value engineering. Develop synthetic routes, validate methods, identify raw material alternatives. Maintain documentation. Support validation & transfers. Coordinate with QA, QC & production.

Education Qualification - Pursuing or completed BSc or MSc in Microbiology, Life Sciences, or Biotechnology What We Want You To Do Execute required activities as part of ISO 13485 and ISO 15189 compliance Undertake activities as part of manufacturing documentation under ISO 13485 Undertake activities in molecular kit development and kit packaging departments Preparation of regulatory document dossier Requirements The candidate must have the ability to execute tasks and document information independently. Have a basic understanding of quality assurance and quality checks Awareness of ISO 13485 and ISO 15189 Skills Keen attention to details. Ability to critically evaluate scientific literature...

Immediate requirement for Executive - Regulatory function for one of the leading pharma company Position : Executive ( Regulatory function ) Educational qualification: MSc/MPharm Experience : 3 to 6 years of relevant experience. CTC : up to 6 LPA Contract Period: 1 Year (It can be extended based on performance ) Work Location : Thane office (Maharashtra) Transport provided : Yes (from Thane station) Working Mode ( Remote / Hybrid ) : Work from office. Shift timings : 9 am to 5.30pm Main Responsibilities: KEY RESPONSIBILITIES 1) To maintain high degree of quality of documents required for submissions to get the approval without deficiency / non-critical deficiency. 2) Timely readiness and sub...

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as deliver...

Regulatory Monitoring & Analysis: Continuously monitor, track, and analyze new and evolving policies, regulations, rules, tariff orders, grid codes, and standards issued by central (e.g., MoP, MNRE, CEA, CERC) and state-level authorities. Required Candidate profile • Permits, Licenses & Approvals Management (Project Lifecycle): Manage the end-to-end process of obtaining all required licenses, permits, and approvals for solar, wind, and hybrid power projects.

You will be joining a global investment bank in a full-time hybrid role as a Manager of Cross-border Regulatory Compliance. This role is based in Bangalore and involves overseeing cross-border compliance, ensuring adherence to international regulations, and managing compliance audits. Your daily responsibilities will include developing and implementing compliance policies, monitoring regulatory changes, and providing guidance on regulatory issues. Additionally, you will collaborate with international teams to ensure consistent compliance practices. Your key responsibilities will include leading the implementation and monitoring of the cross-border controls framework across global Asset Manag...

Optra Scan Pvt Ltd is a renowned provider of digital pathology solutions, transforming the landscape of pathology practices worldwide by streamlining the management and interpretation of diagnostic information. With our innovative technology, we empower pathologists to enhance efficiency, precision, and patient care through the integration of digitalization and artificial intelligence. As a Technical Writer - Regulatory at OptraSCAN, you will play a pivotal role in creating, organizing, and updating regulatory documentation essential for product approvals, certifications, and market entry across global jurisdictions. This position demands a blend of strategic regulatory planning and meticulo...

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical ...

Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y

As a Medical Gas Plant Operator specializing in Engineering & Maintenance, you will be responsible for ensuring the safe and efficient operation of medical gas production equipment and related systems within healthcare facilities. Your primary focus will be on maintaining equipment functionality, overseeing preventive maintenance schedules, troubleshooting operational issues, and ensuring compliance with regulatory standards governing medical gas systems. Key Responsibilities: Equipment Operation : Operate and monitor medical gas production equipment, including compressors, cylinders, storage tanks, and distribution systems, to ensure continuous and reliable gas supply. Preventive Maintenanc...

About Zydus Wellness Zydus Wellness, an FMCG leader, develops, manufactures, and markets health and wellness products, integrating healthcare, skincare, and nutrition. Founded in 1988 with Sugar Free, India’s first zero-calorie sugar replacement, it now manages seven global brands, including Complan, Glucon-D, Everyuth, and Nutralite. The company serves over 50 million families and supports more than 90,000 dairy farmers and 2,000 MSMEs. With a focus on research, quality, and innovation, Zydus Wellness operates on core pillars of manufacturing integrity and supply chain efficiency. Headquartered in Ahmedabad and Mumbai, it runs four manufacturing facilities across India and eight co-packing ...

As the Head of Production, you will play a crucial role in the planning, coordination, and control of manufacturing processes, focusing on Factory Layout and Production Layout. Your responsibilities will include collaborating with internal and external stakeholders to provide technical support, ensuring the production of top-notch products and adherence to best business practices. You will lead and manage teams and projects across the organization, offering clear direction, inspiration, and guidance to drive excellence and motivate staff towards success. Your primary responsibilities will involve designing and validating factory layout and production layout, developing engineering bills of p...

To ensure that products with all regulations and legislation, both National and international,throughout the product lifecycleThe RAP works closely with R&D manufacturing QA/QC and mkt to ensure timely registration,compliance and approval of products

The Candidate will be responsible to the Business Operations for Global as well as Developing New Business Opportunity by focusing on building and growing strong relationship both internally and externally. Devising effective Business Development Strategy for future research-based products with global Clients in Nutraceutical, Dietary & Natural/ Herbal Supplements for all categories. KEY DELIVERABLES: Strategic and Operational Excellence Identifying opportunities to build, develop and strengthen relationships with global clients to grow and sustain the business by strategizing optimum customer selection and management, team expansion and nurturing a healthy cross functional team culture. Ide...

Product Data Mining from regulatory data tools. Engaging with IT to backfill product data into ERP systems. Customer Support on regulatory document requests. Vendor engagement to obtain regulatory documents and data. Ongoing regulatory data analysis and tracking. Analysis of materials properties and compliance status. Support part / material sampling and testing process. Internal global stakeholder engagement in a regulatory support function as needed. Support product compliance with a myriad of current and imminent global regulatory obligations. Qualifications: College Degree (BS) in Chemical Engineering, Chemistry, Material Science or another related field. 3+ years of prior experience in ...

Product Data Mining from regulatory data tools. Engaging with IT to backfill product data into ERP systems. Customer Support on regulatory document requests. Vendor engagement to obtain regulatory documents and data. Ongoing regulatory data analysis and tracking. Analysis of materials properties and compliance status. Support part / material sampling and testing process. Internal global stakeholder engagement in a regulatory support function as needed. Support product compliance with a myriad of current and imminent global regulatory obligations. Qualifications: College Degree (BS) in Chemical Engineering, Chemistry, Material Science or another related field. 3+ years of prior experience in ...

Role & responsibilities Collaborate closely with the Submission Level Publisher to ensure timely and accurate document processing. Perform daily PDF processing tasks as per assigned workload and project requirements. Adhere strictly to submission timelines and regulatory deadlines. Conduct troubleshooting using ISI Toolbox, resolving technical issues efficiently to avoid delays. Execute quality control (QC) checks of PDF files, focusing on: Bookmarking Hyperlinking Table of Contents (TOC) accuracy Implement corrections in processed PDF files based on QC comments or review feedback. Escalate and communicate any processing issues to the Submission Specialist, particularly those involving ISI T...

Qualification: MSc in Analytical / Organic Chemistry Pharmacy Life Science Role Summary: Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance. Key Responsibilities: Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities. Ensure timely updates, maintenance, and life cycle management of submissions. Monitor global regulatory changes and communicate to internal teams. Handle customer queries, letters of access, and technical...

Primary Skills SAP PLM Recipe Development & Management Extensive experience in configuring and managing end-to-end recipe development processes within SAP PLM. Proficient in creating and optimizing formulas, defining ingredient compositions, and ensuring compliance with industry-specific regulations. Strong understanding of managing recipe versions, tracking modifications, and maintaining historical records for transparency and traceability. Specification and Compliance Management In-depth knowledge of handling raw material, intermediate, and finished product specifications. Ability to set up structured specification templates, define critical parameters, and ensure adherence to global regul...

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, an...

Candidate Profile: Minimum qualification should be Graduate in Chemistry (Hons) 2-5 years experience in a chemical laboratory doing analysis or R&D work or having experience in any kind of chemical regulatory work Have good hold on English language Dynamic and disciplined Have ability to do lot of data search on the internet and refer books & journals Have the interest to study and read documents thoroughly to analyse and understand Open to travel both within India and outside related to office work Have the ability to work in team and believes in teamwork Innovative and takes initiative

. Role & responsibilities Knowledge on Medical device regulations Good Communication skills Ability to read through the Medical Device Documents Ability to work on Microsoft tools (Excel, Word and PowerPoint) Experience on Medical Device UDI Data management will be an additional preference Preferred candidate profile Work location: Madurai Education: B.E Mechanical/Bio-Medical Experience: 6 months to 3 yrs Immediate joiners are only preferred. Interested candidates can share your resume to keeshouley.m@hcltech.com. Interview Mode - Scheduled Walkin (Need to report to Madurai premises for Face to Face Interview). Regards, Keeshouley M