Regulatory Compliance Team Lead (Sr Manager) Amgen

2.0 - 8.0 years

0 Lacs

hyderabad, telangana

On-site

The Regulatory Compliance Team Lead will be responsible for overseeing a team of regulatory CMC professionals performing assessment of operational changes for regulatory reportability for Amgen products across phases of development, modality, and countries. This role is accountable for hiring, training and retaining talented regulatory CMC regulatory staff, in alignment with the operational objectives of the wider RA CMC department. They are accountable for continuous improvement, through the development and refinement of processes, and partnership with colleagues in other functions to develop systems and tools that improve the speed and efficiency of operations over time. They exemplify the...

Posted 1 week ago

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Regulatory Compliance Change Assessor - Sr Associate Amgen Inc

2.0 - 6.0 years

2 - 6 Lacs

hyderabad, telangana, india

On-site

Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies. Basic Qualifications: Master's degree Bachelor's degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate's degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Dip...

Posted 2 weeks ago

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Analyst / Specialist - Regulatory Affairs (CMC and Operations) Immuneel Therapeutics Pvt. Ltd.

2.0 - 5.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India and the world. For more details, please refer www.immuneel.com We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy. Working at Immuneel promises the excitement of an agile startup on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in e...

Posted 1 month 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 3 months ago

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