Regulatory Affairs CMC ANDA submissions Executive or Sr Executive Opportune Solutions

4.0 - 8.0 years

7 - 8 Lacs

nelamangala

Work from Office

Handled ANDA submissions with thorough knowledge on review of CMC documents of dosage: Injectables (simple and complex), Ophthalmics, Topicals, Nasal Sprays and Tablets. knowledge on Module 5 requirements with review & upload study reports. Required Candidate profile Experience of eCTD tools - Educe/Lorenz and/or Pharma Ready. evaluate and respond Agency’s Deficiencies. review DMF. USFDA. Experience of handling submissions related to site transfer products

Posted 2 weeks ago

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Senior Submission Publisher SUN PHARMA

8.0 - 10.0 years

0 Lacs

gurgaon, haryana, india

On-site

Title: Senior Submission Publisher Business Unit: Regulatory Operations Global Regulatory & Business Continuity Innovative Medicines Job Grade G10 / Manager Location : Mumbai (preferred) / Gurgaon / Baroda Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we T...

Posted 3 weeks ago

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Submission Publisher Golden Opportunities

3.0 - 7.0 years

0 Lacs

pune, maharashtra

On-site

You have hands-on experience working with the US, Canada, and European Market regions in regulatory publishing and submissions. Your expertise includes managing dossiers, using Lorenz, and working with Docubridge. As a Submission Publisher, you will be responsible for regulatory submissions related to the pharmaceutical industry. This is a full-time, permanent role in the ITES/BPO/KPO sector, specifically within the functional area of pharmaceuticals. You should be well-versed in handling dossiers, using Lorenz software, and working with Docubridge. The job code for this position is GO/JC/20989/2025. Your recruiter for this role is HariharanA.,

Posted 1 month ago

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