Nazneen Shaikh
Experienced professional in Regulatory affairs, SDS authoring
- Role
- Lead Associate at Genpact
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Nazneen Shaikh
Strongly reliable professional with 7 years & 10 months of experience and a proven…
Experience
Lead Associate
Apr 2022 — Present · Mumbai, IN
Provide support as regional planner for renewal submissions including planning, preparation of submission packages and release of renewals to the country.Responsible forimplementing CMC regulatory strategies for assigned pharmaceutical products in accordance with globalregulations, guidance and defined regulatory strategies.Implement proposed variation and formatting changes into the EN language Product Information (PI) files, includingformatting, QRD template check, and archiving in RADR. Coordination of translation rounds for remaining languages.Execute quality check to ensure all changes have been implemented. Submission of all proposed language filesstored in REDS on EMA Day +5 and Day +25 submissions to RAE and EMA. Coordination of notification email to CRA for implementation of member states comments into their pertinent language files.Post approval activities - Closing sequence by changing approval dates, etc. in the document status of all languagesversions in REDS, communication of approval with Doc IDs, review of files on the Community register & EPAR via TVTcheck.
Education
Mithibai College of Arts Chauhan Institute of Science and A.J. College of Commerce and Economics
Masters
2015 — 2017
Mithibai College of Arts Chauhan Institute of Science and A.J. College of Commerce and Economics
Bachelor's degree
2012 — 2015
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.