![NMS Consultant](https://media.trabajo.org/img/noimg.jpg)
Bioequivalence Operations
2 months ago
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
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