Priya Kapoor
Regulatory Affairs Specialist | FDA/EMA Submissions | Quality & Compliance
Email: priya.kapoor@example.com | Phone: +1 (555) 013-7465 | LinkedIn: linkedin.com/in/priya-kapoor-regaffairs | Website: www.regulatory-priya.com
Profile Summary
Results-driven Regulatory Affairs Specialist with 6+ years of experience in global drug and medical device submissions. Proficient in eCTD submission planning, risk assessment, and cross-functional collaboration to ensure 510(k), PMA, EMA dossier, and ISO compliance. Known for meticulous attention to detail, meeting regulatory expectations, and improving submission timelines.
Experience
GlobalBio Solutions, New Jersey, USA | Jan 2021 – Present
Senior Regulatory Affairs Specialist
- Led end-to-end regulatory strategy and submissions for 3 US and EU products, achieving 100% on-time approvals.
- Managed eCTD submissions for NDA/MAA including CMC, labeling, and risk assessment; maintained 2.0x submission readiness.
- Harmonized global labeling and safety narratives with pharmacovigilance teams, reducing post-approval issues by 30%.
NovaPharma Ltd, Mumbai, India | Jun 2018 – Dec 2020
Regulatory Affairs Associate
- Coordinated global regulatory strategy for registrations in US, EU, and APAC; prepared and filed 5 regulatory dossiers.
- Led CMC documentation and risk management; collaborated with QA to ensure GMP/GDP compliance and inspection readiness.
- Streamlined submission timelines by 20% through standardized templates and cross-functional reviews.
Skills
Regulatory Submissions (eCTD, eCTD AMS)
FDA/US Regulatory (510(k), PMA, IND)
EMA & EU MDR/IVDR
CMC Documentation
Labeling & Packaging Compliance
Quality Systems & CAPA
GxP, GMP, GDP Compliance
ICH Guidelines (ICH Q9, Q10, GCP)
Health Authority Liaison
Certifications
- Regulatory Affairs Certification (RAC) – US
- ISO 13485:2016 Lead Auditor
Education
- Master of Science in Regulatory Affairs, University of Maryland, College Park, MD, 2018
- Bachelor of Pharmacy, University of Mumbai, Mumbai, India, 2016