Bioequivalence Operations

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 pre-submission 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