202 Dossier Preparation Jobs - Page 2

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats. Responsible for final review of dossier before submission. Reviewing artwork for products as per relevant regulatory authority requirements. Coordination with F&D, QA, QC & Store for documentation In-depth knowledge of pharmaceutical documentation & regulatory guidelines. To coordinate with technical team for documents required for dossier. Country Experience Preferred: CIS, LATAM Dosage Form Experience: Soild Oral + Injectable Preferred candidate profile

Monitoring daily work activities at Site Produce WPS, PQR & WPQ - Qualification of welders. knowledge of welding, welding process and defects Supervising Non-destructive testing like radiography , penetrate and ultrasonic. Coordination with customer

Role Overview: You will be responsible for utilizing your basic knowledge of pharmaceutical development for Dossier preparation for Global Market, mainly focusing on oral, injection, and topical dosage forms. Additionally, you will be involved in US/European pharmaceutical IP and Regulatory strategy. Your experience in pharmaceutical business intelligence and business case analysis for new project selection and approval will be highly valued. You will interact with various internal and external departments within a multidisciplinary matrix team, showcasing your cross-functional skills, leadership, and motivation. Key Responsibilities: - Identify, evaluate, and monitor Pipeline Projects - Par...

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparat...

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...

Roles and Responsibilities (5 days working) Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets. Handle team responsibilities related to dossier compilation, review, and approval. Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization. Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines. Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation. Desired Candidate Profile M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs. Strong understanding...

Manage timely and professional delivery of regulatory activities for relevant products pro-actively to support the business goals including management of rationalization dossiers & related activities for Export products registration/renewal/variation for drug/ food/ other commodities items Represent organization while responding to regulatory agencies queries and other correspondence after engaging and interacting with regulatory bodies of various countries Preparing, submitting, reviewing regulatory file applications and supporting documentation with all registration related tasks post approval authorization, queries, post approval authorization-variations, renewals, fees (Pharmaceutical, N...

1. Regulatory Affairs: - o Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products. o Liaise with client and regulatory authorities for approvals, clarifications, and queries. o Maintain up-to-date knowledge of regulatory requirements in India and international markets. o Support risk assessment and labeling compliance for products. 2. Toxicology & Safety Evaluation: o Review and interpret toxicology, Endocrine disruptors and ecotoxicology study reports. o Coordinate with external labs/CROs for conducting toxicological and ecotoxicology studies. o Maintain regulatory and toxico...

Position: QC Chemist ( Only Male) Job Location: Nerul, Navi Mumbai Industry: Ayurvedic / Herbal Pharmaceuticals Qualification: B.sc/ Msc Experience: 0-2 Yrs Experience ( Freshers also can apply) Designation & Salary: Commensurate with industry experience and expertise. Working Days And Time: 8:00 AM to 5 PM / 6 Days week / Sunday fixed Off. Key Responsibilities: Smooth functioning and timely analysis & approval of FG, RM,PM & intermediate which is finally approved from Q.C. COA preparation for Export purpose & other documentation whenever required.Monitoring of Control sample observation register: RM & FP Monitoring of Control sample and maintaining destruction record Formats up-gradation fo...

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries. The team member will be responsible for maintaining U.S. state and federal com...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

Position Regulatory Consultant Company Information Our client is a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. They have their head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. The company has been providing high quality & timely consulting service to the Pharmaceutical Industry in India and internationally. The company has a young and committed team of GMP and Regulatory Experts. The company is inviting applications for the role of Regulatory Consultant and are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm. Role & Responsib...

Role & responsibilities 1. Regulatory Strategy & Submissions Develop and implement regulatory strategies for new product development and existing product life cycle management. Review and approve dossiers (CTD/eCTD/ACTD) for submissions in domestic and international markets. Manage new drug applications (NDA), ANDA, IND, DMF, variations, renewals, and post-approval changes . Ensure timely filing of submissions to DCGI, CDSCO, US FDA, EMA, MHRA, WHO, TGA and other authorities. 2. Compliance & Quality Ensure all products comply with local and international regulations, ICH, GMP, and pharmacopoeial standards . Review and approve labeling, artwork, and packaging materials for compliance. Stay up...

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 ...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates a...

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Role & responsibilities 1. Regulatory Strategy & Submissions Develop and implement regulatory strategies for new product development and existing product life cycle management. Review and approve dossiers (CTD/eCTD/ACTD) for submissions in domestic and international markets. Manage new drug applications (NDA), ANDA, IND, DMF, variations, renewals, and post-approval changes . Ensure timely filing of submissions to DCGI, CDSCO, US FDA, EMA, MHRA, WHO, TGA and other authorities. 2. Compliance & Quality Ensure all products comply with local and international regulations, ICH, GMP, and pharmacopoeial standards . Review and approve labeling, artwork, and packaging materials for compliance. Stay up...

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 ...

Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufact...

Regulatory & Licensing Prepare and manage applications for WHO certification, manufacturing & wholesale licenses, renewals, FOSCOS, FDA, and other statutory approvals. Handle CBN export NOCs, biodiversity returns, and related compliance filings. Coordinate with FDA officials (domestic & overseas) during licensing, audits, and certifications. Maintain compliance with cGMP, pharmacopoeial & non-pharmacopoeial standards, and GS1 barcode implementation. Documentation & Dossiers Oversee dossier preparation, submission, and re-registrations for international and domestic markets. Prepare documentation for product registrations, government tenders, and patent projects. Review artwork, promotional m...

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives : Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department. 1. Dossier Preparation and Review Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements. Review dossiers prepared by team members to ensure they meet national and international standards. Provide guidance and technical expertise to the team during dossier preparation. 2. Regulatory Submissions and Approvals Manage applications for licenses, permissions, and other regulatory approvals in the country o...

JD To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all CIS Countries and other country as per company requirements. Responsible for final review of dossier before submission To coordinate with technical team for documents required for dossier. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Provide responses to regulatory agencies regarding product information or issues. Impl...

1) To do the FSSC 22000 Ver 6.0 certification related documentation which includes preparing of SOP's, Formats, Annexures & records 2) To prepare the Standard Operating Procedures w.r.t. Quality and Food Safety requirements so as to improve the Quality Systems at the Site. 3) To prepare and update schedules of the implemented procedures and imparting trainings to the Food Handlers. 4) To Prepare Audit planner and preparing/reviewing Audit Checklist 5) Implementation of CAPA & follow up of same. Essential Skills : Should have Hands on Experience in Handling the Quality & Food Safety Systems and Documentations. Desirable Skill s: Good Communication