7.0 - 11.0 years

0 Lacs

haryana

On-site

As a Regulatory Affairs professional in our company, you will play a crucial role in ensuring compliance with regulatory guidelines and maintaining the highest quality standards in the technical documentation for regulatory filings. Your responsibilities will include: - Conducting CMC review of technical documentation for regulatory filings to various markets, with a focus on the US market - Performing Gap Analysis and Remediation for module 3 -CMC - Developing and implementing regulatory strategies, processes, and timelines for grant of MA in regions like Africas, GCC, LATAM, ASEAN - Reviewing CTD dossiers, variations, change controls, renewals to ensure compliance with regulatory guideline...

Posted 1 week ago

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Manager Regulatory Affairs 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...

Posted 1 month ago

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Assistant Manager Regulatory Affairs DDReg Pharma

4.0 - 8.0 years

0 Lacs

haryana

On-site

You are a proactive and detail-oriented Assistant Manager in Regulatory Affairs (EU & UK) with a Masters Degree in Pharmacy (M.Pharm or equivalent) having 4 to 6 years of experience. You will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines. Your key responsibilities will include conducting comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets, performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards, developing and implementing ...

Posted 3 months ago

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Manager Regulatory Affairs EM DDReg Pharma Pvt. Ltd.

7.0 - 11.0 years

0 Lacs

haryana

On-site

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. Your tasks will include reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. It is essential to critically review documentation intended for su...

Posted 3 months ago

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