Job Description

Position Title:?Regulatory AffairsQualification: Mpharm/ Bpharm MSc/Experience: 2+ YearsLocation: ThaneJob Responsibilities:Preparation & Compilation of the product Dossiers of various pharmaceutical formulations for CIS & ROW Market.Review of all technical documents (BMRs, Process Validation, Method of Analysis, and Analytical Method validation, Stability, API, FP, PM COAs & DMF etc.) recd. from Factory & follow-ups with related departments for the same or correction/up gradation in data so as to have better compilation of dossiers.Answering Queries related to Drug Product Registration.Checking of artworks as per countries requirement.Provide Label Claim of New finished product for License application; checking of Lic. , COPP
Preparation of documents required for BE Studies.To co-ordinate with Q.C., Q.A., Purchase, Production & R&D department for preparation of Dossiers of Pharmaceutical formulations.Co-ordination with R&D Dept. & Support in New product development by providing all the details of new product to R&D. Maintain Update status.
Key Skills: Skill Set:Minimum of 2 years of relevant experience in Regulatory Affairs or related fields in the pharmaceutical industry.Strong knowledge and hands-on experience in preparing regulatory dossiers, especially for CIS and ROW markets.Excellent communication skills in English, both written and verbal.Proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.).Ability to work independently and efficiently under deadlines.Attention to detail and problem-solving abilities.
Location: Mumbai, Mumbai Suburbs, Navi Mumbai, Thane
Required Experience: 2-3 yrs
Positions: 2
Contact Person: Jobs Admin
Email ID: jobs@tmservices.co.in
Qualification:
TMS Spoc:
CTC ( What client is offering):

Team Management Services