2.0 - 6.0 years

0 Lacs

ahmedabad, gujarat

On-site

**Job Description** As a candidate for the position based in Ahmedabad, you will be responsible for the following tasks: - Document preparation for COA MFR PV and stability Data. - Preparation of country specific new ACTD/CTD Dossiers. - Coordinating with artwork department. - Coordinate with F&D, QA, QC, and Production department. - CMC review of technical documentation for regulatory filing in African, LATAM, CIS Countries, and emerging markets. Please email your resume to business@vivanzabiosciences.com.,

Posted 2 weeks ago

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Manager Regulatory Affairs EM DDReg Pharma Pvt. Ltd.

7.0 - 11.0 years

0 Lacs

haryana

On-site

Role Overview: You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. - Critically reviewing documentation intended for s...

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Regulatory Affairs Vivanza Biosciences

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a candidate for the role based in Ahmedabad with Vivanza BioSciences, your key responsibilities will include: - Document preparation for COA MFR PV and stability Data. - Preparation of country-specific new ACTD/CTD Dossiers. - Coordinating with the artwork department. - Coordinating with F&D, QA, QC, and Production departments. - CMC review of technical documentation for regulatory filing in African, LATAM, CIS Countries, and emerging markets. Please email your resume to business@vivanzabiosciences.com to apply for this position.,

Posted 2 months ago

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Manager Regulatory Affairs DDReg Pharma Pvt. Ltd.

7.0 - 11.0 years

0 Lacs

haryana

On-site

Posted 3 months ago

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Regulatory Affairs-CMC- Queries Aurobindo Pharma

1.0 - 3.0 years

1 - 3 Lacs

Hyderabad, Telangana, India

On-site

Preparation, review and compilation of assigned ANDA/NDA [505 b (2)]/projects for filing and knowledge of eCTD, Module 2 and 3. Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms. Preparation, review and compilation of Supplements and Amendments. Review of Pharmaceutical Development Reports Review of manufacturing documents like batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, hold time study reports, master formula cards, master packaging cards etc. Review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer...

Posted 5 months ago

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