5.0 - 10.0 years

3 - 7 Lacs

hyderabad, chennai

Work from Office

We are looking for a Senior STEM Content Analyst with strong expertise in CMC Biologics to join our Life Sciences team in India. The ideal candidate will have a solid background in pharmaceutical development or regulatory affairs, particularly in biologics and biopharmaceuticals, and will be passionate about delivering high-quality content that supports global health authority submissions. About You experience, education, skills, and accomplishments BS degree in Life Sciences. Minimum of 5 years of experience in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs for Biologics/Biopharmaceuticals. Experience managing BLA/MAA content and format. Experience with FDA and EMA...

Posted 1 month ago

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Manager - Regulatory CMC SUN PHARMA

5.0 - 10.0 years

0 Lacs

haryana

On-site

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as deliver...

Posted 5 months ago

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The cleaned title from the string Manager - Regulatory CMC is Manager - Regulatory CMC . SUN PHARMA

5.0 - 10.0 years

0 Lacs

haryana

On-site

The position of Manager is open in the Global Regulatory Affairs Specialty Pharma department. As a Regulatory CMC Product team member, you will provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded products being developed for the US and other advanced markets like EU & Canada. Your responsibilities will include ensuring lifecycle management by submitting annual reports and supplements in a timely manner to ensure product continuity. You will be accountable for the delivery of all regulatory milestones for higher complexity products, including assessing the probability of regulatory success and implementing risk mitigation measures. In thi...

Posted 5 months ago

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