Senior Executive RA

IPMS Placements Pvt. Ltd.
  • Bangalore, Chennai, Hyderabad
  • 2-9 lakh
  • 2-5 years
  • Views
  • 13 Jul 2017

  • Legal

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Planning, reviewing & submission for assigned ANDA & NDA projects within timelines. Adherence to High quality & regulatory standards in dossiers, Review & submission of Annual reports (ANDAs/NDAs), Knowledge of eCTD, Module 2 &3, US regulatory filing
Candidate Must Have 2-4 years of EXP. in Injectable (RA) US market, Should have experience in US market in CMC sections (Mod 2&3) , *Labeling & Module 1 experience will be added advantage

Competencies/Skill sets for this job

Projects Planning Reviewing Submission

Job Posted By

About Organisation

IPMS Placements Pvt. Ltd.