Bioequivalence Operations - Mumbai, India - NMS Consultant

NMS Consultant

Verified Company

Mumbai, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

From 10 to 15 year(s) of experience

₹ Not Disclosed by Recruiter

Mumbai (All Areas)
Reviewing all bioequivalence study protocols and reports so as to ensure the quality and to meet regulatory requirements.
Resolving queries raised by regulatory authorities after submission of registration dossier and presubmission queries raised by our customer
Planning for future studies i.e. CRO identification, selection and budget negotiation
To undertake audit of identified CROs along with CQA team for evaluating their services & procedures, quality assurance and quality control systems along with infrastructure and personnel to conduct our BE studies
Resolving issues arises from R&D and internal regulatory department
Handling all pharmacokinetic studies required for domestic clinical trials and Phase I studies
Reviewing clinical trial protocols planned for International markets
To coordinate with project team members from research and development, regulatory affairs, analytical development, location and accounts internally and with different CROs and vendors externally.

Key Skills
- croresearch developmentclinical researchbioequivalence

Protocolsquality controlClinical Study Reportregulatory requirementsAnalytical DevelopmentcqaDossierMpharmregulatory affairsclinical trialspharmaQuality Assurance
Skills highlighted with '' are preferred keyskills

Education

PG:_M.Pharma in Any Specialization

Company Profile:

NMS Consultant

Leading Pharmaceutical Company

Company Info

Salary:

Not Disclosed by Recruiter

Industry:
Pharmaceutical & Life Sciences

Department:
Research & Development

Role Category:
Pharmaceutical & Biotechnology

Role:
Clinical research Scientist

Employment Type:
Full Time, Permanent