Senior Regulatory Manager Biocon Biologics

0.0 years

0 Lacs

bengaluru, karnataka, india

On-site

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, a...

Posted 1 month ago

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Project Manager Regulatory Compliance CoreIT Services Pvt. Ltd.

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As a Project Manager for critical regulatory projects, you will be responsible for overseeing Operational Resiliency and PIPA Compliance initiatives. Your key duties will involve managing the projects from start to finish, including planning, execution, and delivery. Additionally, you will be tasked with coordinating with stakeholders, providing regular updates, and ensuring risk and compliance are effectively managed. It is crucial to maintain adherence to regulatory timelines and standards throughout the project lifecycle. The ideal candidate for this role should have a proven track record of successfully managing regulatory or compliance-focused projects. Holding a PMP or equivalent proje...

Posted 1 month ago

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