Neeta Joshi
Associate Regulatory Specialist- Ra Clinical @Novo Nordisk
Signup · Get unlimited contacts
WORK HISTORY
Associate Regulatory Specialist- Ra Clinical @Novo Nordisk
Bengaluru, IN
In my current role, I lead the regulatory strategy and submission planning for diabetes products, utilizing Veeva Vault RIM to manage complex regulatory submissions, including NDAs and renewals. I ensure compliance with global health authority requirements and maintain readiness for product launches by managing global core labeling and lifecycle activities. My responsibilities also include engaging with health authorities and overseeing pharmacovigilance documentation. Achievements: Successfully led regulatory submissions for multiple products, ensuring timely approvals and compliance with health authority requirements. Developed and maintained global core labeling, acting as Change Owner for Labelling Change Requests, which enhanced regulatory compliance across markets.
EDUCATION
National Institute of Pharmaceutical Education and Research (NIPER), Mohali (NIPER).
M.S Pharma, Masters in Pharmacy
Kendriya Vidyalaya
HSC
Kendriya Vidyalaya
SSC
Baroda College of Pharmacy, Gujarat University
Bachelor of Pharmacy (B.Pharm.), Pharmacy
SKILLS
ABOUT NEETA JOSHI
Associate Regulatory Specialist with over 14 years of experience in global regulatory affairs, specializing in regulatory strategy, submissions, and compliance across diverse markets including the EU, LATAM, APAC, and more. My career has been dedicated to ensuring timely access to innovative therapies for patients worldwide by leading regulatory submissions and lifecycle management. I thrive in cross-functional environments, collaborating with teams to drive strategic outcomes and enhance regulatory processes.Throughout my career, I have successfully managed complex regulatory submissions, including NDAs and post-approval changes, while ensuring compliance with global health authority requirements. My expertise extends to labeling strategy, pharmacovigilance oversight, and regulatory process transformation. I have a proven track record of engaging with health authorities and leading initiatives that optimize regulatory operations. I am passionate about leveraging my skills to contribute to the success of global regulatory strategies.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.