19 Dossier Compilation Jobs

Roles and Responsibility : To review and arrange required documents to corporate RA for dossiers, query response. To review artwork in artwork management system. R apply product permission, NOC for all manufactured product.R

Knowledge on Regulatory guidelines for API & Finished product registration. Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets. Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling of customer and MOH queries. Coordination with cross-functional teams & Reviewing of Documents (Specification, MOA, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Should have hand on experience in handling ODLS, FSSAI, Sugam Portal for Licensing of Drug & Food Products. Prior knowledge on Administrative document applications (COPP, GMP, Free sale and Import License). Registration information management system updates on regular basis. Requirements Bachelors/Masters degree in Biotechnology/ Microbiology/ Pharmacy/ Regulatory Affairs. 1-4 Years of experience as Regulatory Affairs Executive in Pharmaceuticals. Interpersonal and communication skills Planning and organizing skills

Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

Role & responsibilities Regulatory Strategy Development : Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions. Identify regulatory pathways for new product launches and lifecycle management of existing products. Regulatory Submissions and Approvals : Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for injectables across multiple jurisdictions (e.g., Africa, CIS, LATAM). Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines. Compliance Management : Ensure that all pharmaceutical products (particularly injectables) comply with regulatory requirements in target markets across ROW. Review product labeling, packaging, and advertising materials to ensure compliance with local regulatory guidelines. Manage post-market surveillance requirements, including reporting adverse events (AEs), product recalls, or any regulatory non-compliance in the region. Cross-functional Collaboration : Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle. Provide regulatory input and support during the product development phase, particularly for injectables, which often require more complex regulatory scrutiny. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements. Regulatory Intelligence : Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice), GxP, and other relevant policies across various countries in ROW. Act as the internal subject matter expert on regulatory issues related to injectables in ROW markets. Monitor competitor activities and regulatory trends in the ROW regions, particularly for injectables. Regulatory Affairs Leadership : Lead and manage a team of regulatory professionals across the ROW regions, guiding their work in regulatory submissions and compliance activities. Provide mentoring and training to team members to enhance their regulatory knowledge and skills, particularly in the injectables segment. Risk Management & Problem Solving : Identify and mitigate regulatory risks related to the approval process for injectables in target regions. Address regulatory challenges or delays and take proactive steps to resolve issues, including negotiating with health authorities or addressing deficiencies in submissions. Regulatory Advocacy and Relationship Management : Build and maintain strong relationships with key regulatory authorities in various ROW regions, including ministries of health, regulatory bodies, and industry associations. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations and injectables. Documentation & Reporting : Maintain accurate and comprehensive regulatory files and documentation for products, especially injectables, in compliance with regional regulations. Provide regular updates to senior management on regulatory milestones, challenges, and market access status. Preferred candidate profile Must have experience into injectables dosage forms.

We are seeking a QA-RA Executive to join our dynamic team. The ideal candidate will be responsible for the preparation, compilation, and submission of regulatory dossiers as per CTD/ACTD/eCTD, country-specific regulatory requirements. The role will also involve supporting the QA-RA team in various regulatory tasks and ensuring compliance with applicable regulations and standards. Key Responsibilities: Dossier Preparation and Submission : Responsible for the preparation, compilation, and submission of assigned regulatory dossiers in line with CTD/ACTD/eCTD formats, country-specific requirements for regulatory agencies. Regulatory Compliance : Ensure compliance with regulatory guidelines, ensuring all submissions meet quality standards and deadlines. Additional Tasks : Perform any other tasks as assigned by the reporting manager or senior team members. Backup and Reporting : In the absence of the primary responsible person, handover responsibilities will be managed to a designated colleague. Functional reporting to be done as per the department's organogram. Qualifications: Educational Background : B.Pharma , M.Pharma , B.Sc , or M.Sc in a relevant field. Experience : Minimum 1 year of experience in a regulatory affairs or quality assurance role. Maximum 5 years of experience in a similar position, preferably in the pharmaceutical or healthcare device industry. Technical Skills : Knowledge of Dossier preparation according to CTD/ACTD/eCTD guidelines. Strong understanding of regulatory requirements in healthcare, pharmaceutical, or medical device industries. Desired Skills: Strong attention to detail and high levels of accuracy. Ability to work efficiently under pressure and manage multiple tasks. Excellent communication skills (both written and verbal). Team player with a proactive attitude and problem-solving ability.

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research and Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radio pharma, Allergy Immunotherapy, CDMO Sterile Injectable, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radio pharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company's Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectable business offers manufacturing services including sterile fill and finish injectable (both liquid and lyophilisation), full-service ophthalmic offer (liquids, ointments and creams) and ampoules. The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Find out more about us at www.jubilantpharmova.com . The Position Organization- Jubilant Pharmova Limited Designation - Deputy Manager / Manager - Regulatory Affairs Location- Nanjangud, Mysore Responsible for following activities of Head -Technical Services, Design and Engineering Department: Preparation/review and submission of new dossiers and updates for global markets. Preparation/review and submission of responses to queries from regulatory authorities/customers. Provide technical regulatory support to CRD for various activities (route of synthesis, starting material designation, specifications design, applied testing methodologies, Analytical method validations) related to new product development and other regulatory issues as they arise. Review of R and D technical packages for new product development (NPD) as well as cost/quality improvement process (CIP/QIP) for regulatory adequacy. Coordination with R and D to discuss on process and product controls, quality, patent and special studies to respond the queries from regulatory authorities/customers. Tracking of activities status to meet the timeline for new Submissions, Responses and Life cycle management of Dossiers. Preparation/review and submission of technical packages and open parts as per customer requirement. Review of technical packages for out sourced starting materials and intermediates for regulatory adequacy.; Review of analytical method validations, characterization data, process validations, analytical data, specifications/test methods, BMRs, packing material details, and stability data etc. w.r.t. regulatory adequacy for dossier compilation. Review of CSO/stability protocols [EDMS] and change controls (track-wise) related to facility, manufacturing process and control of materials etc. for regulatory adequacy. Attending to and lsquo;on the job trainings' and and lsquo;off the job trainings'. Updating health authority new guidelines to Regulatory affairs team. Person Profile. Education Qualification: MSc / M.Pharma,/ B.Tech / M.Tech Chemical Engineering Experienc e Range : 10+ years in API Regulatory Affairs Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. To know more about us, Please visit our LinkedIn Page- https://www.linkedin.com/company/jubilantpharmova/mycompany/

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research and Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radio pharma, Allergy Immunotherapy, CDMO Sterile Injectable, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radio pharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company's Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectable business offers manufacturing services including sterile fill and finish injectable (both liquid and lyophilisation), full-service ophthalmic offer (liquids, ointments and creams) and ampoules. The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Find out more about us at www.jubilantpharmova.com . The Position Organization- Jubilant Pharmova Limited Designation - Deputy Manager / Manager - Regulatory Affairs Location- Nanjangud, Mysore Responsible for following activities of Head -Technical Services, Design and Engineering Department: Preparation/review and submission of new dossiers and updates for global markets. Preparation/review and submission of responses to queries from regulatory authorities/customers. Provide technical regulatory support to CRD for various activities (route of synthesis, starting material designation, specifications design, applied testing methodologies, Analytical method validations) related to new product development and other regulatory issues as they arise. Review of R and D technical packages for new product development (NPD) as well as cost/quality improvement process (CIP/QIP) for regulatory adequacy. Coordination with R and D to discuss on process and product controls, quality, patent and special studies to respond the queries from regulatory authorities/customers. Tracking of activities status to meet the timeline for new Submissions, Responses and Life cycle management of Dossiers. Preparation/review and submission of technical packages and open parts as per customer requirement. Review of technical packages for out sourced starting materials and intermediates for regulatory adequacy.; Review of analytical method validations, characterization data, process validations, analytical data, specifications/test methods, BMRs, packing material details, and stability data etc. w.r.t. regulatory adequacy for dossier compilation. Review of CSO/stability protocols [EDMS] and change controls (track-wise) related to facility, manufacturing process and control of materials etc. for regulatory adequacy. Attending to and lsquo;on the job trainings' and and lsquo;off the job trainings'. Updating health authority new guidelines to Regulatory affairs team. Person Profile. Education Qualification: MSc / M.Pharma,/ B.Tech / M.Tech in Chemical Experience Range : 6+ years (in API Regulatory only) Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. To know more about us, Please visit our LinkedIn Page- https://www.linkedin.com/company/jubilantpharmova/mycompany/

JOB SUMMARY: The role is part of the Global Regulatory Function, responsible to prepare qualitative, error free product registration dossiers for different geographies. JOB RESPONSIBILITIES: Compiling, organizing, and reviewing documentation required for regulatory submissions. Ensuring compliance with relevant regulations and guidelines, collaborating with cross-functional teams, and managing timelines to meet submission deadlines. Attention to detail, knowledge of regulatory requirements, and effective communication skills are crucial for success in this role. REQUIRED EDUCATION AND EXPERIENCE: Min 5 years of relevant experience in Agri industry M.Sc. (Agriculture, Chemistry, Toxicology) MS office skills (Word, Excel, PowerPoint) Excellent written and verbal skills, high attention to detail

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. Gathering of technical information from various sources. Preparation of Dossiers, Submission of dossiers. Preparation of applications to regulatory bodies for all necessary approvals. FDA, CDSCO, international regulatory bodies. Review of dossiers of pharmaceutical products Answering queries of regulatory bodies connected with product registration. Overseeing of the regulatory process filing necessary applications and handling all government interactions. Coordinating the inspection of the organization facilities and contract facilities, and developing procedures to ensure regulatory compliance. Managing subordinate staff in the day-to-day performance of their jobs. Ensuring that project/department milestones/goals are met while adhering to approved budgets. Accompanying development projects and revising already existing technical documentations. Communicating with responsible regulatory authorities (national/international) as well as with notified bodies. Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of pharmaceuticals products and nutritional supplements. Training team members to fulfill their job functions and improving their skills. Staying informed about any changes in legislation etc. Skills needed Indian FDA guidelines knowledge Understanding & knowledge of standards of various international regulatory bodies SA/ZAZIBONA/EU. Organizational Skills- Work assignment, time management, working within strict time frames. Ability to solve regulatory queries & compliance matters. Knowledge of dossier types and filing requirements. Responsibilities of a Regulatory Executives / Officers : To prepare and compile registration dossier as per the specific country guidelines and submit to regulatory authorities. To prepare, review compile re-registration documents. To prepare & review /check artwork, pack insert, SmPC etc. To study Regulatory guideline of assigned countries and to prepare checklist / template for registration dossier. To verify specification of excipients, active, finished product and packaging material and all required documents. Application, review, co-ordination, follow-up of legal documents COPP, FSC etc. Maintain Proper database w.r.t to master document dossier. To collect and verify all technical documents and information from various departments at the manufacturing site. Provide Regulatory support to various departments. Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose. To reply any queries raised by respective regulatory authority, in timely manner. To maintain and update Registration certificate /information in regulatory data base. Requirement : Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW, EU and Other country. Regulatory Affairs Manager - 5 +10 years experience of working in the regulated markets Regulatory Affairs Senior Executive / Officers - more than Two years experience in Pharma Regulatory Affairs will be preferred Required Candidate profile for Manager Level Effective oral and written communication skills. Must be flexible and capable of managing personnel Must have a systematic approach to solving problems. Must be able to keep calm and make quick, clear decisions while coping with pressure. Must be able to understand the techniques and processes used Excellent PC skills , should be proficient with the usage of the internet as a tool to find necessary & useful information. Must be organized- timely, and with information/data

Role & responsibilities Post Approval Pre Approval Dossier Compilation Life Cycle Management Preferred candidate profile Europe Market

We have opportunity in Regulatory Affairs for Emerging Markets Position: Officer/Executive Regulatory Affairs Experience: 2-5 Years Qualification: B.Pharm/M.Pharm Location: Pune Compilation of dossiers in CTD, eCTD & national formats Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for new product filing Maintaining product Life cycle Candidates having experience LATAM/CIS/ Africa or any other Emerging Markets can apply If relevant and interested, pls apply

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Senior Executive/Assistant Manager/ Deputy Manager based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 7 - 15 yrs. with dossier filling experience in MEXICO or South East Asian Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Compilation and review of product license applications, variations, and renewals for Mexico country as per regulatory requirements respectively with minimal supervision Manages electronic documents and creates electronic submissions in CTD format. Preparation and review of responses to authority questions during registration and product lifecycle. Keep track of assigned projects and follow-ups to ensure the Dossier is delivered as per set timeline/commitments. Designing, Reviewing & Approval of Artwork required for registration purposes. •Dossier due diligence for products being in-licensed from other company Support in preparing the meeting materials as needed, eg, regulatory project status/ submission/ approval information monthly, quarterly or yearly. Interested professionals may share their CVs to janihimanshu@alembic.co.in stating position code RA-MEXICO” in subject line

Job Title: Senior Executive Drug Regulatory Affairs (DRA) Job Responsibilities: Prepare and review regulatory dossiers in compliance with country-specific guidelines, including CTD, ACTD, and other regional formats. Manage dossier submissions for new registrations, re-registrations, and product variation filings. Review quality and administrative documents to ensure completeness and accuracy before submission. Conduct literature searches to compile non-clinical and clinical data for dossier preparation. Develop and review SmPCs, Package Inserts, and labeling information in accordance with regulatory requirements and initial dossier submissions. Evaluate and approve artwork for export products. Collaborate with cross-functional departments including QA, QC, Production, ADL, and R&D to streamline regulatory processes. Address and resolve queries from regulatory authorities such as the FDA and other relevant agencies. Maintain communication with international clients regarding dossiers, sample requirements, and regulatory updates. Draft and review applications for product permissions, COPPs, and FSCs. Market Exposure: ASEAN: Philippines, Vietnam, Myanmar, Laos, Cambodia, Thailand Africa: Uganda, Nigeria, Ethiopia, Mozambique, Tanzania, Cameroon, Ivory Coast, Benin, Burundi, Togo, Congo, ZaZiBoNa, South Africa LATAM: Peru, Ecuador, Bolivia, Guatemala, Nicaragua, Costa Rica CIS: Kyrgyzstan, Uzbekistan, Russia, Ukraine Other Regions: Georgia, Sri Lanka, Azerbaijan

Role & responsibilities Regulatory Strategy Development : Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions. Identify regulatory pathways for new product launches and lifecycle management of existing products. Regulatory Submissions and Approvals : Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for injectables across multiple jurisdictions (e.g., Africa, CIS, LATAM). Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines. Compliance Management : Ensure that all pharmaceutical products (particularly injectables) comply with regulatory requirements in target markets across ROW. Review product labeling, packaging, and advertising materials to ensure compliance with local regulatory guidelines. Manage post-market surveillance requirements, including reporting adverse events (AEs), product recalls, or any regulatory non-compliance in the region. Cross-functional Collaboration : Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle. Provide regulatory input and support during the product development phase, particularly for injectables, which often require more complex regulatory scrutiny. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements. Regulatory Intelligence : Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice), GxP, and other relevant policies across various countries in ROW. Act as the internal subject matter expert on regulatory issues related to injectables in ROW markets. Monitor competitor activities and regulatory trends in the ROW regions, particularly for injectables. Regulatory Affairs Leadership : Lead and manage a team of regulatory professionals across the ROW regions, guiding their work in regulatory submissions and compliance activities. Provide mentoring and training to team members to enhance their regulatory knowledge and skills, particularly in the injectables segment. Risk Management & Problem Solving : Identify and mitigate regulatory risks related to the approval process for injectables in target regions. Address regulatory challenges or delays and take proactive steps to resolve issues, including negotiating with health authorities or addressing deficiencies in submissions. Regulatory Advocacy and Relationship Management : Build and maintain strong relationships with key regulatory authorities in various ROW regions, including ministries of health, regulatory bodies, and industry associations. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations and injectables. Documentation & Reporting : Maintain accurate and comprehensive regulatory files and documentation for products, especially injectables, in compliance with regional regulations. Provide regular updates to senior management on regulatory milestones, challenges, and market access status. Preferred candidate profile Must have experience into injectables dosage forms.

- Handling vendor approval requests – filling forms, Questionnaires, sharing FAQ, documents etc. - Handling regulatory requests / queries from customers. - Maintenance of regulatory documentation in electronic format and saving key communication. Required Candidate profile - 2+ years of experience in Pharma Regulatory Affairs. - B.Pharm / M.Pharm - Good Communication skills, Time Management and IT skills

Well versed with regulatory requirements of Brazil, South Africa, Australia Able to deliver output in terms of registration approvals Experience in variation filings Good knowledge of CTD dossiers & publishing in above countries Documentation Review