11 Dossier Compilation Jobs

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates working in formulations may skip this job post.

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier compilation for ACTD & CTD is mandatory. Coordination with the external stakeholders for the preparation of the regulatory documents. To be responsible for the Life cycle management of assigned products. Should have experience for Life cycle management and license Maintenance. Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Desired Candidate Profile Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Perks and Benefits Best in industry. Immediate Joiners preferred

* Collaborate with cross-functional teams on regulatory strategy . Stay current with evolving regulations related to Sulphur import/export in different countries, including customs regulations, trade agreements, and safety standards Annual bonus Provident fund Accidental insurance

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