Executive Regulatory Affairs

GenNext Human Resource Management
  • Surendranagar
  • 3-5 lakh
  • 3-8 years
  • Views
  • 08 Feb 2018

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Ensure timely submission of CTD & ACTD dossiers in ASEAN/Emerging/Regulated Countries. Ensure timely submission of post-approval maintenance activities such as variation, labeling and CMC changes, supplements,Compliance to dossier commitments,CMC Desired Candidate Profile Candidate should have knowledge of CMC requirements, impact of post approval changes and regulatory life cycle management.Good exposure in ASEAN/ Emerging/ Regulated Countries for formulation. Ready to relocate to Surendranagar.

Competencies/Skill sets for this job

Ctd Ra Regulatory Affairs DRA CMC Drug Regulatory Affairs

Job Posted By

Gyanendra Singh
Business Head