88 Dossier Preparation Jobs

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 , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc

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 analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile

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 regulatory and code of conduct requirements; 7.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. 8.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 9. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 10. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. .

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 consultants and agents for submissions and queries. Product Lifecycle Management: Manage variations, renewals, query responses, and product registration maintenance. Handle change control and post-approval regulatory activities. Document Control: Maintain updated regulatory records and submission trackers. Ensure timely and organized archiving of all submitted dossiers and correspondence.

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 relevant regulatory bodies across countries. Resolving deficiencies and queries from customers, partners, and regulatory agencies will also be part of your role. You will assist in the development of Regulatory Affairs Standard Operating Procedures (SOPs) and ensure adherence to internal audit requirements as per Quality Management System (QMS) standards. Participating in risk-benefit analysis for regulatory compliance and identifying, planning, and implementing process improvement initiatives are also key aspects of your responsibilities. To qualify for this role, you must hold a graduate degree in Science, Engineering, or Pharmacy. A minimum of 2 years of experience in global regulatory requirements of products, processes, and procedures is required. Experience in product compliance or product stewardship is preferred. You should be able to work independently without supervision and communicate effectively, both in writing and orally, with technical and non-technical colleagues. As a problem solver, you should be able to identify issues, review related information, develop and evaluate options, and implement effective solutions. Managing parallel projects and sometimes competing deliverables to meet project delivery dates will also be part of your job scope.,

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 Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Cards (MFC), and process validation protocols. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable

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 project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

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 process. Job Responsibilities 1) Quality Risk Management 2) Batch Manufacturing Record preparation 3) Process Validation 4) Packaging Material Specification Preparation 5) APQR 6) Cleaning Validation 7) Regulatory Affairs activity 8) Dossier preparation 9) Application of ONDLS system 10) Form 29 & Form 30 preparation 11) Endorse documents preparation 12) New drug application 13) COPP application in ONDLS.

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 preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master File, BMR, APR etc. Should be able to communicate with relevant functions for procurement of required regulatory documents Should be able to communicate with relevant business partner at country

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 this role, you will lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Additionally, you will provide regulatory leadership in product in-license/due diligence review, product divestment, and product withdrawal. Managing the execution of CMC documentation, supporting new technology development, and ensuring compliance with a focus on regulatory affairs will also be part of your responsibilities. You may also be required to manage or mentor junior team members. As a candidate for this position, you are expected to have hands-on expertise in the preparation & review of dossiers, response to queries, and communication with agencies for developed markets like the US/EU. Your experience in critically reviewing detailed scientific information, demonstrating superior oral and written communication skills, and understanding related fields such as manufacturing, analytical, and quality assurance will be crucial. Your ability to generate innovative solutions to complex regulatory problems, work effectively with key stakeholders, and demonstrate flexibility in responding to changing priorities will be highly valued. To qualify for this role, you should have a minimum of 5-10+ years of experience in regulatory affairs, with proficiency in English and additional language skills considered a plus. Strong inter-personnel skills, the ability to direct multi-departmental functions, and effective leadership, communication, interpersonal, and negotiating skills are essential for this position. A Master's degree in Pharmacy (M. Pharm) in pharmaceutical sciences is required for this role.,

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 Search Strategy, AMV, CDP, BE Study. Experience Required: CDSCO , USFDA, EUGMP, NAFDAC Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

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 submission of regulatory dossiers to health authorities for new drug applications, variations, renewals, and post-market surveillance reports. Ensuring adherence to all applicable regulatory requirements, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and labelling regulations. Building and maintaining strong relationships with regulatory agencies, proactively addressing any concerns or queries regarding product submissions. Managing and developing a team of regulatory professionals, including regulatory affairs managers, specialists, and associates, ensuring their expertise is utilized effectively. Education: B Pharm/M Pharm with exposure in Regulatory Affairs for 15 to 20 years in pharma. Desirable Skills & Competencies: Deep understanding of global pharmaceutical regulations, including ICH guidelines and relevant regional regulations. Extensive experience in the drug development process, from pre-clinical to post-market surveillance. Proven leadership skills in managing and motivating a regulatory affairs team. Excellent communication, negotiation, and interpersonal skills to effectively interact with regulatory agencies and internal Stakeholders. Interested candidates can mail their updated resume & CTC on sumit.s@titanpharma.com. Thanks & Regards, Sumit Shirke HR Department Titan Laboratories Pvt Ltd

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 and commercialization. 8. Conduct training sessions on regulatory updates and internal System 9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations. 10. Support internal and external audits by providing required regulatory documents and justifications. 11. Guide and review work of junior team members or trainees. 12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates. 13. Review of all dossiers related technical documents Preferred candidate profile Experience in reviewing of Analytical documents

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 internal systems and processes. 4. Product Lifecycle Management: Handle renewals, variations, and responses to regulatory queries/deficiencies. Maintain product registration databases and archival of regulatory submissions. 5. Liaison & Communication: Coordinate with regulatory authorities, agents, and external consultants as required. Attend audits and respond to regulatory inspections

Regulatory compliance, dossier preparation, CER, risk management (ISO 14971), audit support, CDSCO/FDA licensing, SOP drafting, validation reports, NPD change control, ,ensuring product certification in domestic ,international medical device markets Required Candidate profile B.Pharm, M.Pharm, Biomedical Engineering, Life Sciences, Regulatory Affairs Certification. Perks and benefits Food, PF, Medical Insurance