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Dy Manager/Manager- Regulatory Affairs- ROW - Formulations Shilpa Medicare

5.0 - 10.0 years

7 - 14 Lacs

Hyderabad/Secunderabad

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Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits

Posted 1 week ago

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MicroStrategy Developer Consult Asia (opc)

7 - 12 years

20 - 27 Lacs

Chennai, Bengaluru, Noida

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Design and develop MicroStrategy objects, dashboards, and cubes; optimize SQL; support data warehouse design; use Object Manager; migrate Cognos reports; provide client support and suggest BI enhancements. Required Candidate profile Experienced MicroStrategy Developer with strong SQL, DB2, and data warehousing skills. Proficient in dashboards, Object Manager, and Cognos migration. Expert in troubleshooting and client-facing

Posted 2 months ago

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Regulatory Affairs Executive Icpa Health Products

1 - 3 years

3 - 5 Lacs

Mumbai Suburbs, Mumbai, Mumbai (All Areas)

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Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers Coordinate with factory Required Candidate profile 1-3 Years Experience In Regulatory Affairs for formulations Excellent communication skills both written and verbal

Posted 2 months ago

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Regulatory Affairs (US/EU - Formulations) - Senior Manager / Team Lead Shilpa Medicare

10 - 15 years

20 - 25 Lacs

Hyderabad

Work from Office

Roles and Responsibilities Should handle a team of 4-10 members. Must have experience into formulations US - ANDA/NDA and EU Generic/Hybrid applications. Should be familiar with oral solids and parenteral dosage forms. Should familiar with pre and post approval regulatory activities. Should handle the customer and Agency queries. Should handle other regulatory activities based on organization need. Should support plant RA activities and other CFTs as needed. Desired Candidate Profile Perks and Benefits

Posted 2 months ago

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RA Executive Renown Pharmaceuticals

4 - 6 years

3 - 4 Lacs

Vadodara

Work from Office

Expertise in ROW market, understanding nuances in regulatory demands across regions in-depth knowledge of FDA Guidelines to ensure compliance in documentation and submissions. Proficiency in handling technical documents to facilitate accurate and timely submissions Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance Strong analytical skills to assess regulatory data and provide critical insights for decision-making Experience in dossier preparation, organizing comprehensive documents for regulatory authorities Attention to detail to meticulously handle documentation and regulatory records Excellent communication skills to liaise with regulatory agencies and internal departments Preparation of registration dossiers as pe regulatory guidelines Preparation of renewal application as per renewal guidelines Facilitate query response raised by regulatory authority and customers Preparation and submission of Safety, Quality & administrative variations as per variation guidelines

Posted 2 months ago

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