279 Dossier Preparation Jobs

Job Title : Officer - Documentation Functional Area : QA Key Accountabilities Technical and QMS Documentation: Preparation and Review of Documents as per ISO 13485, EU-MDR, 21CFR820, Thai FDA and Indian Medical Device Rule and ensure implementation of same. Handling of Deviation, Non-Conformance, Change controls and CAPA. Handling of Post market surveillance Preparation of the regulatory documents (TMF/Dossiers) for regulatory submission. Preparation of Technical files in co-ordination with R&D Team. Preparation of Design file as per ISO 13485:2016, MDR and USFDA. Handling of Adverse event reporting to EU and other regulatory body. Familiar to handle Eudamed, Maude and other databases Valida...

Dear All, We are looking for a Regulatory Affairs Assistant Manager/Deputy Manager with 7-9 years of experience in pharmaceutical formulations, specifically for the US market . Key Responsibilities: Defining Regulatory strategies for submission for US market Review of team who are responsible for preparation and compilation of the dossiers in CTD/eCTD and other formats as required for submission to different regulatory authorities. Review of dossiers in CTD/eCTD for US market. Review & approval of Batch Records, Specifications and STP etc. Responding to queries /deficiencies received from regulatory authorities. Monitoring of timely submission of Labeling Initials, Amendments, Labeling Suppl...

1. Regulatory Strategy & Planning 2. Dossier Preparation & Submission 3. Collaborating with in-market consultant / team 4. Lifecycle Management 5. Compliance & Intelligence 6. Cross-functional Collaboration

Role & responsibilities Prepare, review, and submit regulatory dossiers for product approvals, renewals, and variations in compliance with local and international regulations. Ensure all regulatory submissions are complete, accurate, and timely in alignment with organizational objectives. Maintain updated knowledge of regulatory requirements, guidelines, and changes across domestic and international markets. Coordinate with R&D, QA/QC, production, and marketing teams to gather technical data required for submissions. Manage regulatory databases, track approval timelines, and ensure documents are archived systematically. Respond to queries from regulatory authorities and provide clarification...

Were Hiring | Regulatory Affairs Professionals with minimum 5+ years of hands-on Regulatory Affairs experience Global Markets | Pharma Industry Rusan Pharma is expanding its Global Regulatory Affairs team, and we are looking for experienced Regulatory Affairs professionals with strong exposure to international markets. Open Positions – Regulatory Affairs: Regulatory Affairs – Canada & ANZ Region Regulatory Affairs – SEA (Southeast Asia) Region Regulatory Affairs – CIS Region What We’re Looking For: Hands-on experience in Regulatory Submissions & Lifecycle Management Exposure to international regulatory agencies (Region-specific experience mandatory) Strong understanding of dossier preparatio...

Dear All, We have opening for Regulatory Affairs (Formulations) - Sr. Executive for Regulatory Market where we are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! Role & responsibilities 1. Should be able to compile, review regulatory dossiers independently. 2. Review and respond to customers & ministry queries. 3. co-ordination with all stake holders to collect required documents. 4. Market Reg Market (EU, UK, TGA, New Zealand, South Africa) Education - B.Pharm / M. Pharm Desired Skills Strong understanding of CTD / ACTD, ICH . Proficiency in dossier preparation and compilation of regulatory documents Excellent attention to detail , document...

Job Title: Sr. International Regulatory Affairs Company: Pharma Location: Ahmedabad Experience: 3-8 Years CTC: 3.50 to 8.0 LPA WP: 7383005000 Required Candidate profile Candidate must have experience in pharma company in regulatory affairs department

We are looking for Sr. Manager / AGM - Regulatory Affairs handling Regulated Market(US, EU, UK, Australia, etc.) in pharma. Details are as below - 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 strate...

Role Overview: As an Assistant Manager in Global Portfolio & Business Development at Intas, you will be responsible for having basic knowledge of pharmaceutical development for Dossier preparation for the Global Market, particularly focusing on oral, injection, and topical dosage forms. Your expertise in US/European pharmaceutical IP and Regulatory strategy will be crucial. You will also be involved in pharmaceutical business intelligence and business case analysis for new project selection and approval. Your role will require interaction with various internal and external departments within a multidisciplinary matrix team, showcasing your cross-functional skills, leadership, and motivation....

Role & responsibilities: To support and manage regulatory submissions, product registrations, and lifecycle maintenance activities in compliance with global regulatory requirements, ensuring timely approvals and sustained market authorization of pharmaceutical and life science products. Key Responsibilities Prepare, review, and submit regulatory dossiers (CTD / eCTD) for regulated and semi-regulated markets Handle product registrations, renewals, variations, and amendments Compile and maintain CTD Modules 15 as per regulatory guidelines Respond to regulatory authority queries, deficiency letters, and commitments within defined timelines Coordinate with QA, QC, R&D, Production, Packaging, and...

Role & responsibilities 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, MENA, CIS and ROW 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. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. 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 acco...

Responsibilities: * Manage regulatory dossiers from start to finish * Ensure compliance with ROW market requirements * Prepare CTDs and ACTDs for product approvals * Collaborate with cross-functional teams on regulatory strategy

Key Responsibilities 1. Dossier Preparation & Submission Prepare, compile, review, and submit EU CTD/eCTD dossiers (Modules 15) for pharmaceutical finished formulations. Ensure accuracy, completeness, and compliance of dossiers as per EU guidelines (EMA/ICH). Coordinate with internal teams (R&D, QA, QC, F&D, Packaging) for timely collection of data required for dossier compilation. 2. Regulatory Strategy & Planning Develop regulatory strategies for new product development for EU markets. Assess regulatory requirements for new molecules, new dosage forms, and technology transfers. Provide regulatory inputs during product development and scale-up stages. 3. Variations & Post-Approval Activitie...

- Compilation & review of AMV, PV data - Preparation of CTD and ACTD dossier modules - Complete dossier preparation as per ROW market, Latam - Handling of regulatory queries - Follow up with client's regulatory - Job allocation to the subordinates

As a Regulatory Affairs Lead, your role will involve leading and supporting filing activities for Biosimilars, NCEs, and ANDAs in emerging markets such as Japan, Canada, ANZ. You will be responsible for query responses, audit support, and lifecycle management. Additionally, you will provide regulatory support for the filing of IND/CTA to various regulatory agencies. Your duties will also include the maintenance of IND/CTA by submitting protocol amendments, adding investigators, obtaining EC approvals, submitting SAE reports, and preparing quarterly/annual reports. Key Responsibilities: - Lead/support filing activities for Biosimilars, NCEs, and ANDAs in emerging markets (Japan, Canada, ANZ) ...

* 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.

Department - Regulatory Affairs (Formulation) Role & responsibilities - Preparation of successful pharmaceutical license application to Global Regulatory agencies. Reviewing regulatory documents such as manufacturing batch records, packaging batch records, analytical method, validation protocol and reports, stability protocol and record cards. Responsible for co-coordinating with cross-departmental teams such as Contract Lab and Contract Manufacturer for timely submission if required, collection of documents, review of documents and resolving any regulatory discrepancies. Responsible for compiling regulatory documents including Quality Module of Dossier for Global market as per regional requ...

Company Name: Exemed Pharmaceuticals Designation - IRA Officer/Sr.Officer Location - Vadodara ( Corporate Office) Role & responsibilities Prepare, review, compile and submit regulatory dossiers (CTD/ACTD/Country specific format). Communicate with cross functional team for CMC documents, review and provide feedback to team. Keep up-to-date with changing global regulations. Communicate regulatory updates to internal teams. Maintain updated regulatory files and technical documents till Product life cycle management. Respond to regulator queries received from Internal and External stake holders within timeframe. Review of artworks as per labelling requirement of various countries for regulatory ...

Purpose/Objective The Coordinator Regulatory at Adani Realty in Mumbai plays a crucial role in ensuring compliance with all regulatory requirements related to construction projects. This position requires 2-4 years of experience in the Construction industry. The ideal candidate will have a strong understanding of regulatory frameworks and possess exceptional organizational skills. Key Responsibilities of Role - Ensure adherence to all regulatory requirements and standards for construction projects. - Coordinate with internal teams to obtain necessary permits and approvals. - Maintain up-to-date knowledge of relevant laws and regulations. - Prepare and submit regulatory documents and reports ...

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...

Prepare, review, and maintain regulatory documentation. Prepare dossiers. Assist in filing applications, registrations, renewals. Freshers & experienced can also apply.

Prepare/review CTD/eCTD dossiers; manage registrations, renewals & variations; handle regulatory queries; support audits; coordinate with R&D/QA/QC/Production; ensure global compliance; review labeling; maintain regulatory documentation.

We are looking for Manager- Regulatory Affairs handling Regulated Market (US, EU, UK, Australia, etc.) in pharma. Manage registrations, submissions, GCP/GMP compliance, liaise with authorities and lead the regulatory team. Required Candidate profile Deep understanding of global pharmaceutical regulation, including ICH guideline and relevant regional regulation. Experience in drug development process, from pre-clinical to post-market surveillance. Perks and benefits Personal Accident Policy Mediclaim Policy

Job Description: We are looking for a Regulatory Affairs Associate with 4 to 10 years of experience in managing CMC aspects, dossier compilation, and submission for US, EU, and Brazil markets. This role will focus on leading the preparation of high-quality regulatory submissions and managing complex CMC documentation for various dosage forms, including solid or injectable products. Key Responsibilities: Independently compile and review submission dossiers in CTD/eCTD format for regulatory authorities like US FDA, EMA, and ANVISA. Review CMC documentation for regulatory compliance, strategize filing categories, and ensure submissions are completed within deadlines. Conduct due diligence for n...

Preparation & Compilation of Dossier in ACTD / CTD format as per standard guidelines of the countries Handling of Daily activities of D.R.A. department Review of Technical documents and samples for registration purpose. Preparation of documents as per specific requirement of the countries. Knowledge of legal documents and Authority's Regulatory documents such as NOC, Product Permission, COPP, FSC, Manufacturing licenses, GMP, WHO GMP etc. Responsible for Preparation / Reviewing of :- (i) MSDS (ii) Package Insert/PIL (iii) Drug Master File (IV) RMP Product Artwork checking & approval in regulatory aspects for export and maintain their records. Ability to work productively in a team environmen...