Executive/Sr Executive-Regulatory Affairs

Executive/Sr Executive-Regulatory Affairs

Job Description

1.preparation of registration dossiers for semi regulated and regulated markets.

2.Compilation and review of plant and R&D documents

3.Response to letters from various health authorities

4.Checking/reviewing of documents as per regulatory requirements

5.guide site for regulatory filing documentation

6.maintenance of lists/documents/records

7.co-ordinate with QA/production


Desired Profile
Regulatory experience in regulated markets,knowledge of various country requirements,ICH.

Experience in sterile formulation filings

Experience 3 - 4 Years
Industry Type Pharma/ Biotech/Clinical Research
Role Regulatory Affairs Mgr
Functional Area Healthcare, Medical, R&D
Education UG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Compensation: compensation will be at par withh industry standards
Location Mumbai
Keywords regulatory affairs,Regulated markets,dossiers,documentation, sterile formulation
Contact USV Limited
B.S.D Marg, Govandi,
MUMBAI,Maharashtra,India 400088
Website http://www.usvindia.com

Email : hrd@usv.co.in

Posted in: Executive-Regulatory Affairs