image

sign in | sign up
Home > Candidates > SUKANYA SAHA
SUKANYA SAHA

BOSTON Massachusetts, US

Phone: xxx-xxx-xxxx

Email: xxx@xxxx.xxx



  • Looking For: Regulatory Affairs Specialist, regulatory affairs analyst

  • Occupation: Business and Finance

  • Degree: Master's Degree

  • Career Level: Entry Level

  • Languages:

Career Information:
Sign up to view SUKANYA SAHA's full profile.

Highlights:

Skills:Regulatory Affairs Manager, Regulatory Affairs Senior Specialist, Assistant Manager, Regulatory Affairs
Experiences:
Education:

NMIMS University 06/2012 - 08/2016
, , United States
Degree: Bachelor's Degree
Major:Pharmacy
Coursework: Pharmaceutics, Pharmaceutical Management, Pharmaceutical Engineering, Biostatistics & Computer Applications, Pharmacology, , Medicinal Chemistry, Pharmacovigilance, Regulatory Affairs, IP Laws Lab work: Chromatography, electrophoresis, tablet compression & testing techniques, ELISA, HPLC, purity assays

MCPHS University 09/06/2016 - 05/05/2018
BOSTON, MA, United States
Degree: Master's Degree
Major:Regulatory Affairs
• Strategize regulatory submissions & documentation of: 510K, PMA,IDE, IND, NDA, &A, BLA, CMC Analysis, IVD, Orphan drug & Paediatric Drug Development for US-FDA, EU-EMA, Japan-PMDA, Canada, Brazil, Australia & China • Proficient in Medical Device Regulations, Design & Change control management, MDR, labelling, compliance with Global QMS, CAPA, Verification & Validation, Post-marketing Surveillance • Expertise in interpretation & application of FDA 21 CFR (720,800,812,820) & ICH guidelines, various technical files like DMF, DHF & CTD, Risk Assessment & Adverse Event Reporting
Download Resume(Available to Employers Only):

Login to view resume: Sukanya Saha -



More About SUKANYA SAHA
Please sign in or sign up an employer to view SUKANYA SAHA's personal information.

  • Phone: xxx-xxx-xxxx
  • Email:xxx@xxxx.xxx
  • Visa: -
  • Work Authorization: -
  • Expected Salary: -
  • Intests & Hobbies: -
Employers also viewed:
Aarti Ohri

locbentonville, US

Abhishek Prasad

locMoscow, US

Angela Sidrak

loc, Australia

Josephine Pereira

locMebane, US

Sarah Donoghue

locSuffern, US

Iris Gupta

locMercer Island, US

Kristine Mae Mendez

locCagayan de Oro City, Philippines

Leonard D'Arrigo

locAlbany, US