13 Dossier Submission Jobs

Regulatory Submission & Approvals , Compliance & Documentation, Liaison & Communication, Latam Countries, Complaint Handling Share updated Cv Jobs@asmohlab.com

Responsibilities: * Oversee regulatory affairs processes * Manage dossier submissions & preparations * Ensure compliance with the Latam market requirements * Lead row market strategies * Client query resolution. * Artwork review.

We are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines, and handling ROW, LATAM, SEA, Africa, Pacific market approvals. The candidate will also coordinate BE studies, manage lifecycle activities, review technical files, liaise with authorities, maintain regulatory records, and mentor junior team members.

Job Description Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Job Overview The Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities, country distributors or external partners. Will work closely and train other junior regulatory staff. Key Stakeholders: Internal External partners, Country Distributors, Health Authorities Key Stakeholders: External Cross-Functional Teams Reporting Structure Reports to: Senior General Manager-Regulatory Affairs Direct Reports: Yes Essential Qualification...

If you are a Project Engineer Specialist, Emerson has an exciting role for you! We are looking for an Instrumentation Project Engineer to work for our Pressure Management Business unit at Mahindra World City, Chengalpattu. You will need to have good knowledge and skills in skid assembly, electrical wiring, instrumentation, AGA codes, and meeting customer/project technical specifications. Your responsibilities will include liaising with third parties on testing the skids and obtaining approvals/clearance. You will also be analyzing drawing, GAD, P&ID inspection techniques, control plans, and quality plans. Your responsibilities will involve having a good knowledge of ISO standards, expertise ...

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration Medical device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Office cab/shuttle Annual bonus Health insurance Provident fund

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...

Looking for someone from chemical background not pharma Relevant Experience with Skills and Key Responsibilities: Responsibilities 1) The regulatory specialist will assist IDS senior staff to research (monitor, analyze and create) content regarding global chemical regulatory compliance for industrial / specialty / household /cosmetics / agricultural /pesticides / biocides hazardous and non-hazardous chemicals and products. 2) Strong regulatory research and analytical skills as demonstrated by 2+ years relevant industry experience 3) Ability to understand and apply scientific, and technological knowledge and the regulatory law to the particular needs of the customers in global geographies for...

Role & responsibilities We are seeking a detail-oriented and knowledgeable Executive Drug Regulatory Affairs to manage the preparation, compilation, submission, and post-submission activities related to herbal formulation dossiers for domestic and international regulatory authorities. The ideal candidate should have a strong understanding of herbal product regulations, excellent documentation skills, and the ability to manage regulatory queries effectively. Key Responsibilities: Prepare, review, and compile regulatory dossiers for herbal medicinal products in compliance with country-specific regulations . Ensure that all documents are accurate, complete, and meet submission timelines. Coordi...

Regulatory Submissions Publisher – Mumbai/Bengaluru (Night Shift). Prepares & QC’s regulatory dossiers (IND, NDA, CTA, BLA, IMPD, MAA) for US, EU, Canada, ANZ. Handles EDMF, COS/CEP, MRP/DCP/CP filings Required Candidate profile Requires 2+ yrs pharma publishing exp, Documentum/Liquent Insight skills, MS Office proficiency. Must have international BPO exp, grad degree, and be based in Mumbai/Bangalore. No ex-TCS candidates.

Key Responsibilities will include : 1) Experience in technical review and compilation of registration dossiers for regulated markets. 2) Review of master documents (Specifications, MFR, BMR, BPR, PVP, PVR, HTSP, HTSR, PDR, elemental impurity risk assessment, nitrosamine risk assessment, stability protocols), DMF. 3) Deficiency management for products filed to regulated markets.

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexitie...

RESPONSIBILITIES Author high- quality CMC documentation for US FDA submissions for Post approval supplements/Annual reports in accordance with latest guidance assuring technical congruency and regulatory compliance. Tracking labeling updates and handle corresponding CBE-0 filing. Provide support in PADER submissions. Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends Co-ordination with stakeholders on a regular basis to extend all technical support required from regulator...