Lead Associate - Regulatory Affairs
- Genpact India
- 4 to 5 Yrs
- Mumbai
- 5 years ago
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Job Description
* With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us. Are you the one we are looking for We are inviting applications for the role Lead Associate,Regulatory affairs We are looking for some who should be open to work in any shift as per the business requirement. Responsibilities:- Work with the Graphic Arts Specialist to create artwork for printed packaging components.
- Proofread text for labeling of pharmaceutical products as required by FDA (21 CFR 201).
- Ensure that labeling artwork and proofs meet all medical, legal and regulatory requirements.
- Ensure the accuracy of commercial packaging components.
- Connect with labeling managers in India to ensure any new US regulations are incorporated.
- Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised text on labeling components.
- Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for FDA submission and production (including sup-port of product launch).
- Provide input for internal tracking database in order to control workflow and to ensure FDA submission and/or production deadlines are met.
- Be responsible for assigning a unique text number to the package inserts ensuring the use of an accurate version.
- Provide editorial support to DRA managers by reviewing package inserts (new and revised) to ensure SPL/PLR compliance.
- Configuring new sites and SharePoint for RA
- Monitoring bandwidth usage and in and out knowledge for handling SharePoint.
- Deleting old files to save space
- Running and maintaining backups within the RA
- Deploying custom features
- Enthusiasm & confidence
- Adhere to our principles and values.
- Time Management skills.
- Team Working Skills
- Active listening & Resourcefulness
- Any Graduate/Post Graduate
- Pharmacy/Science
Employement Category:
Employement Type: Full timeIndustry: IT - SoftwareRole Category: General / Other SoftwareFunctional Area: Not ApplicableRole/Responsibilies: Lead Associate - Regulatory AffairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai+ View Contact
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Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and ...
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