Senior Executive/ Assistant Manager - Regulatory Affairs

GenNext Human Resource Management
  • Hyderabad
  • 4-7 lakh
  • 5-8 years
  • Views
  • 26 Mar 2018

  • Legal

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Responsible for Preparation of Module -1 for Emerging Market (Asia, Africa, CIS & MENA) & National Regulatory Filings (CDSCO) Expertise in creating the applications, its related sequences as per submission using the eCTD Software (i.e., Pharmaready). Desired Candidate Profile - Responsible for Handling of CBE-0 and CBE-30. Supporting the team in eCTD compilation for Asia, Africa, CIS & MENA filings and Publishing. Supporting the team in preparation of responses for amendments.


Competencies/Skill sets for this job

Regulatory Affairs Asia CIS Africa Injectable DRA RA

Job Posted By

Gyanendra Singh
Business Head