Executive - Regulatory Affairs SUN PHARMA

0.0 years

0 Lacs

vadodara, gujarat, india

On-site

Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations. Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations. Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates. Coordination of labeling related activities with cross functional teams for timely launch of products. Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares. Communication with third parties or p...

Posted 2 days ago

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Compliance Manager (Pharma) - USFDA Expert Lezivia Lifesciences

5.0 - 9.0 years

0 Lacs

madurai, tamil nadu

On-site

As a Compliance Manager at Lezivia Lifesciences, a reputed pharmaceutical company known for its quality products, your role will involve ensuring that all pharmaceutical practices meet USFDA regulations. Your responsibilities will include: - Conducting regulatory audits to assess compliance levels - Providing compliance training to staff members - Developing and maintaining compliance documentation - Implementing compliance programs effectively - Staying updated with regulatory changes to ensure adherence to standards - Collaborating with various departments to uphold compliance standards To excel in this role, you should possess: - Experience with USFDA regulations and compliance requiremen...

Posted 3 weeks ago

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Executive - Regulatory Affairs SUN PHARMA

0.0 years

0 Lacs

vadodara, gujarat, india

On-site

Posted 4 weeks ago

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Quality Assurance Manager AMN Life Science Pvt. Ltd.

10.0 - 15.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Company Description AMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and Kala Amb (Himachal Pradesh), AMN Life is equipped to handle large scale production and tech transfer projects. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, UK, Australia, and Philippines, AMN Life excels in providing quality medicines at affordable prices globally. We are recognized for our strong global presence, innovative R&D,...

Posted 1 month ago

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Laboratory Information Management System (LIMS) | Pharma - Senior Manager EY

10.0 - 14.0 years

0 Lacs

karnataka

On-site

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. As part of our EY-ER- Regulatory Compliance team, you will help clients by understanding their business needs and translating their strategies into realities through innovation. As a Regulatory Compliance Associate Director, you will actively establish, maintain, and strengthen internal and external relationships. In line with our commitment...

Posted 2 months ago

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