3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As the Regulatory Operations Specialist for the assigned specialty programs (NCE/BLA), your primary role will involve handling various regulatory operations activities. This will include CTA applications in EU, LATAM, USA, Canada, and ROW, CTIS management, submission management, eCTD publishing of all modules, and document management. It is crucial for you to have a thorough understanding of current Global Regulatory filing requirements and eCTD/CTIS structure. Your responsibilities will also include collaborating with Strategists (Leads) and coordinators to develop submission strategies and timelines. You will be responsible for preparing Regulatory Management Plans and Submission content p...

Posted 6 days ago

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Regulatory Specialist- CTA SUN PHARMA

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

Candidate shall be responsible for assuming the role for the assigned specialty programs (NCE/BLA) and be accountable for regulatory operations activities. This includes, but is not limited to, CTA applications in EU, LATAM, USA, Canada, ROW, CTIS management, submission management, eCTD publishing of all modules, document management, etc. It is essential to have a comprehensive understanding and stay updated with current Global Regulatory filing requirements and eCTD/CTIS structure. You will collaborate with Strategists (Leads) and coordinators for submission strategy and timelines. Moreover, you will be required to prepare Regulatory Management Plan and Submission content plan for CT. The r...

Posted 2 months ago

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Sr. Manager Regulatory Affairs Amgen Technology Private Limited

7.0 - 11.0 years

7 - 11 Lacs

Hyderabad / Secunderabad, Telangana, Telangana, India

On-site

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. ...

Posted 5 months ago

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