Neha Gudur
Regulatory Affairs | 8 years\' Experience | EU and International Markets
- Role
- Regulatory Affairs Associate Ii at Teva Pharmaceuticals
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Neha Gudur
Senior Executive Regulatory Affairs with over 8 years of expertise in dossier submission and post-approval activities, including administrative, safety, and CMC changes via eCTD submissions. At Teva Pharmaceuticals, I focus on EU post-approval activities, PSUR submissions, ensuring meticulous CMC maintenance and database management. My role also includes guiding junior team members and contributing to specialized projects that reinforce regulatory pathways. With a Post Graduation Diploma in Quality Assurance, I am adept at navigating pharmaceutical regulations and maintaining marketing authorization applications in compliance with local and international standards. I specialize in managing end-to-end regulatory submissions, effectively collaborating with international cross-functional teams, and utilizing strong communication skills with a proactive approach to problem-solving and team leadership.
Experience
Regulatory Affairs Associate Ii
Sep 2022 — Present · Navi Mumbai, IN
EU post approval activities\\\\n• CMC maintenance of products\\\\n• Maintain of database and system documents\\\\n• Guide junior team members\\\\n• Work on other specialized projects as defined by managers of RA
Education
Sophia College, Mumbai
Post Graduation Diploma
SIES College of Arts, Science & Commerce SION(W)
Bachelor's degree
2011 — 2014
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.