Senior Officer - Drug Regulatory Affairs (DRA) Talent Corner Hr Services

3.0 - 7.0 years

2 - 7 Lacs

navi mumbai

Work from Office

Prepare, review and submit EU regulatory dossiers, manage eCTD, variations and renewals, coordinate with cross-functional teams, ensure EU compliance, handle queries, and maintain regulatory databases. Required Candidate profile B.Pharm / M.Pharm. Hands-on experience with EU regulatory submissions. Strong knowledge of EU CTD/eCTD format. Good understanding of regulatory guidelines &compliance.

Posted 3 days ago

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Cell Culture Specialist Biocon Biologics

0.0 - 4.0 years

0 Lacs

chennai, tamil nadu

On-site

Role Overview: As a Cell Culture Specialist, you will be responsible for supporting Upstream process development, Process Scale up, and Process characterization for mAb manufacturing. You will develop and establish scalable and robust processes to meet desired product yield and quality. Additionally, you will assess risks and actively plan for risk mitigation strategies during process development and scale up. Collaboration with cross-functional teams within RND & other departments like manufacturing, quality control, and quality assurance for technical discussions related to process development, technology transfer, and process improvement will also be part of your role. You will participat...

Posted 1 week ago

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Regulatory Affairs Associate I Teva Pharmaceuticals

1.0 - 3.0 years

0 Lacs

navi mumbai, maharashtra, india

On-site

Role: Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics) Primary purpose of the role: The role of GRO Regulatory Data Analytics is to: Manage Teva's data in accordance with requirements for xEVPMD in order to maintain Teva's Article 57 compliance Provide a Central Data Service for the creation and maintenance of GRA product registration data in line with the global needs of Teva Global Regulatory Affairs. Provide SME services for data management in current and future regulatory data systems The primary purpose of this position is to execute the operations and services applicable to the GRO Regulatory Data Analytics role in line with business goals and objectives...

Posted 2 months ago

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Cell Culture Specialist Biocon Biologics

0.0 - 4.0 years

0 Lacs

chennai, tamil nadu

On-site

As a Cell Culture Specialist, you will play a key role in supporting Upstream process development, Process Scale up, and Process characterization for mAb manufacturing. Your responsibilities will include: - Developing and establishing scalable and robust processes to meet desired product yield and quality. - Assessing risks and actively planning for risk mitigation strategies during process development and scale up. - Collaborating with cross-functional teams within RND and other departments like manufacturing, quality control, and quality assurance for technical discussions related to process development, technology transfer, and process improvement. - Participating in technology transfer a...

Posted 3 months ago

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