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Clinical Research - Executive Torrent Pharmaceuticals

2 - 6 years

4 - 9 Lacs

Gandhinagar, Ahmedabad

Work from Office

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up *Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M. Pharm (Pharmacology) with 2-6 Yrs of Relevant Experience Interested candidates can share their CVs on meghamaheshwari@torrentpharma.com / vilshashah@torrentpharma

Posted 1 month ago

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Regulatory Affairs -Liasoning QPS Bioserve

8 - 12 years

10 - 15 Lacs

Hyderabad

Work from Office

Role & responsibilities: Prepare and manage regulatory submissions (e.g., Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), marketing authorization submissions). Ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and local regulations. Track regulatory timelines and manage submission deadlines for new drug applications, clinical trials, and so on. Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To have experience in the Ethics Committee related activities. To liaison with Local Drug Authorities (DCGI/CDSCO) for regulatory approvals of Test Licenses, Amendments, for conducting BA/BE clinical studies in India. Timely notification to DCGI/CDSCO for study related updates Communicate with regulatory agencies to clarify requirements and resolve issues related to clinical trial approvals and submissions. Manage responses to regulatory queries and facilitate interactions between the client and regulatory bodies. To search literature on healthy population to support BA/BE NOC application To liaise CBN for regulatory approvals for conducting clinical studies in India. To coordinate with global regulatory authorities for regulatory strategic for various products and services Proactive co-ordination of all the necessary activities required regulatory submission. Preferred candidate profile: Education : Bachelor's degree in life sciences, pharmacy, or related field (Masters or advanced degree preferred). Experience : 5+ years of experience in regulatory affairs within a CRO or pharmaceutical/biotech industry, with at least 2 years in a managerial role. Knowledge : In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH), clinical trial regulations, and submission processes. Interested applicants can apply with their updated profile or Can send to email to hr@qpsbioserve.com

Posted 3 months ago

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Clinical Research - Executive Torrent Pharmaceuticals

1 - 6 years

4 - 9 Lacs

Gandhinagar, Ahmedabad

Work from Office

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up *Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M. Pharm (Pharmacology) with 2-8 Yrs of Relevant Experience Interested candidates can share their CVs on vilshashah@torrentpharma / meghamaheshwari@torrentpharma.com

Posted 3 months ago

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