37 Dossier Compilation Jobs - Page 2

We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.

2-7 years of experience in Europe CTD dossier preparation Module-1,2,3,4 & 5 Compiling & submitting technical dossiers for export markets Receiving the site registration requirements Query Response Management Preparation of variation data package Perks and benefits Weekly off on all SATURDAYS & SUNDAYS

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

We are hiring an International Regulatory Affairs Executive/Manager with expertise in regulatory documentation, CTD dossiers & query handling. Immediate joiners preferred. Candidates with 1+ year experience may also apply. Join our growing team!

Expertise in API / Formulation regulatory compliance across EU/ROW regions Sound knowledge of Drug Substance control strategies Familiarity with global regulations: ICH, FDA, EMA, USFDA etc Skilled in responding to Ministry of Health (MoH) queries Required Candidate profile M. Pharma / B. Pharma / M.Sc / B.Sc with 7 to 15 Years Experience Deep Knowledge of Regulatory Affairs Compliance And Procedures Must be able to work independently And Head Team of junior Officers

Position: Asst. Manager Qualification: M.Pharm /B.Pharm/M.Sc. having 8+ years experience in EU/ LATAM market Job profile: 1. Responsible for the designated regulatory projects with respective deadlines 2. Expertise in authoring CMC documentation for EU MAA and post-approval submissions with hands-on experience on using eCTD software Good coordination skills with stakeholders on regular basis to source the documents in accordance with project timelines Review the documents against the Agency guidances assuring regulatory compliance Keep knowledge up to date about regulatory guidelines 6. Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc) Position: Sr.Officer/ Executive Qualification : M.Pharm /B.Pharm/M.Sc. having 4-6 years experience in US market Job profile: 1) Author and compile CMC documentation for ANDA filings and post-approval submissions 2) Coordination with stakeholders on regular basis to source the documents in accordance with project timelines 3) Review the documents against the FDA guidances assuring regulatory compliance 4) Keep knowledge up to date with regard to regulatory guidelines 5) Hands-on experience on using eCTD software Position: Officer Qualification : M.Pharm /B.Pharm/M.Sc. having 2-3 years experience in US market Job profile: 1) Author and compile CMC documentation for ANDA filings and post-approval submissions 2) Coordination with stakeholders on regular basis to source the documents in accordance with project timelines 3) Review the documents against the FDA guidances assuring regulatory compliance 4) Keep knowledge up to date with regard to regulatory guidelines 5) Hands-on experience on using eCTD software Position: Asst. Manager/ Sr.Exexcutive Qualification : M.Pharm /B.Pharm/M.Sc. having 8+ years experience in US market Job profile: 1) Responsible for the designated regulatory projects with respective deadlines 2) Expertise in authoring CMC documentation for ANDA filings and all post-approval submissions 3) Good coordination skills with stakeholders on regular basis to source the documents in accordance with project timelines 4) Review the documents against the FDA guidances assuring regulatory compliance 5) Keep knowledge up to date with regard to regulatory guidelines 6) Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)

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. 1. Dossier Preparation and Review Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements. Review dossiers prepared by team members to ensure they meet national and international standards. Provide guidance and technical expertise to the team during dossier preparation. 2. Regulatory Submissions and Approvals Manage applications for licenses, permissions, and other regulatory approvals in the country of manufacture and export destinations. Coordinate with relevant regulatory authorities to resolve queries and ensure timely approvals. 3. Task Management and Timeliness Ensure timely completion of departmental tasks, adhering to internal and external deadlines. Prioritize assignments and allocate resources effectively to maintain productivity. 4. Compliance Assurance Ensure that all regulatory guidelines are strictly adhered to during product manufacturing and export processes. Stay updated on changes in regulatory requirements and communicate updates to the team. Coordinating the inspection of the organization facilities and contract facilities and developing procedures to ensure regulatory procedures to ensure regulatory compliance 5. Team Leadership and Development Supervise and mentor the regulatory affairs team, fostering a culture of collaboration and accountability. Conduct performance evaluations, provide feedback, and identify training needs for team members. 6. Documentation and Reporting Maintain accurate records of all regulatory submissions and approvals. Prepare regular progress reports for senior management, highlighting achievements, challenges, and solutions. 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 : Strong oral/written communication, leadership & problem-solving skills. Ability to stay calm under pressure and make quick decisions. Proficient in relevant techniques, processes, PC & internet research. Well-organized with timely data/information management.