202 Dossier Preparation Jobs - Page 5

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

The ideal candidate for this role should hold a degree in MSc/M.Pharm/B.Pharm and have a solid experience of 4-8 years in Regulatory affairs. The primary responsibilities will include dossier preparation and timely responses. This is a full-time permanent position with benefits such as provided meals, health insurance, paid sick leave, and provident fund. The work schedule will consist of day shifts with fixed timings. The preferred candidate would have a total work experience of 2 years. The work location will be on-site.,

* B.Pharm/M.Pharm with 4-6 years in Regulatory Affairs, experience in dossier preparation, and country-specific formats. * Prepare dossiers, handle queries, manage re-registration and renewal applications.

Hiring for DRA Manager Location- Panchkula Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit Interested One share resume 9815675900

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations : a. Prepare and review variation...

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap ...

1.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 Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the re...

Key Responsibilities: Dossier Compilation: Prepare, compile, and review regulatory submissions (CTD/ACTD format) for ROW & emerging markets. Work on Module 1 (administrative/legal), Module 2 (summaries), and Module 3 (quality) for OSD products. Ensure dossier accuracy, completeness, and alignment with country-specific requirements. Regulatory Compliance: Ensure all documentation complies with ICH , WHO , and respective country-specific guidelines . Maintain awareness of evolving regulatory requirements across ROW markets. Coordination & Liaison: Coordinate with internal teams: QA, QC, Production, Packaging, and F&D for data collation. Liaise with external stakeholders like regulatory consult...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

As an Associate Regulatory Affairs, your primary role will be to assist in obtaining and maintaining regulatory approvals for beauty, health, wellness, cosmetics, and food products. It is crucial to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. Your responsibilities will include preparing dossiers that are country and category-specific for domestic and international markets to ensure error-free and timely submissions according to department timelines. You will be responsible for coordinating with suppliers and vendors to maintain product master data. Additionally, you will review, prepare, submit, and coordinate with r...

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

Dear All, We are looking for a Regulatory Affairs Executive with 2-4 years of experience in pharmaceutical formulations, specifically for the ROW (Rest of World) market . Hands-on experience in the preparation and submission of regulatory dossiers in CTD and ACTD formats for Rest of the World (ROW) markets. Proficient in drafting and submitting responses to regulatory queries within stipulated timelines. Experienced in managing post-approval activities, including renewals and variations. Skilled in handling Drug Master File (DMF) notifications. Adept at reviewing and ensuring the accuracy and compliance of quality documents such as product specifications, stability data, Product Development ...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into pro...

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 6 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing proce...

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...

The position of Manager is open in the Global Regulatory Affairs Specialty Pharma department. As a Regulatory CMC Product team member, you will provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded products being developed for the US and other advanced markets like EU & Canada. Your responsibilities will include ensuring lifecycle management by submitting annual reports and supplements in a timely manner to ensure product continuity. You will be accountable for the delivery of all regulatory milestones for higher complexity products, including assessing the probability of regulatory success and implementing risk mitigation measures. In thi...

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

Responsible for overseeing al aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leading the preparation and su...

Role & responsibilities 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development an...

Preparation of dossiers for semi-regulated & non-regulated markets. Responding to queries raised by the Ministry of Health (MOH) & buyers regarding dossiers. Coordinating the dispatch of samples(working standards & finished products) for registration Required Candidate profile Collecting documents required for tenders & completing relevant questionnaires. Liaising with plants & internal departments to gather necessary documents and samples, Supporting the Sectional Head.

Preparation/compilation of registration,re-registration Dossier and Application as per country guidelines,Coordination,Reviewed Artwork pertaining to New Registration &renewal, Product Sample-Documentation& Supporting. Share Cv on jobs@asmohlab.com

1. Regulatory Submissions: Preparation and compilation of dossiers in CTD/eCTD formats for domestic and international markets (ROW countries). Submission of registration applications for new products and variations (post-approval changes). 2. Documentation: Review and verification of technical documents such as Product Information Leaflets, Labels, SPC, COAs, Stability Data, Product Development Reports, etc. Coordination with R&D, QA, QC, and production teams for required documents and data. 3. Regulatory Compliance: Ensure products and documentation comply with applicable regulations and guidelines (ICH, WHO, FDA, EMA, CDSCO, etc.). Monitor regulatory changes and ensure timely updates to in...