Regulatory Affairs- Executive/ Sr. Executive- Head Office

4 - 6 Years
Mumbai

Job Description

  1. Independently handling eCTDsubmissions / publishing for EU / Canada / other markets.
  2. - CMC knowledge is compulsory.
  3. Preparation and submission of dossier to various markets within timeline (EU, CIS).
  4. Review of CMC technical documents as per regulatory requirements.
  5. Review and compilation of technical documents for dossier preparation.
  6. Coordination with internal and external clients.



Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Pharma - Pharmacy

PG:MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy

Company Profile

Rusan Pharma Ltd

Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 - 82 Crs., Expected by March 2009 â€" 150 Crs.
View Contact Details+

Recruiter Name:Ms Shalini Singh

Contact Company:Rusan Pharma Ltd

Telephone:9004979276

Email :ssingh@rusanpharma.com

Address :plot no 58 D,Govt Ind estate