Role & responsibilities Evaluate project inquiries for feasibility and conducted thorough assessments to ensure alignment with company capabilities and objectives.Coordinate for scientific discussions and goals pertaining to bioavailability / bioequivalence (BABE) studies with customers.Coordinate with sponsor and cross functional team members for finalization of CDA, MSA, Rate Contracts and other project related contracts and agreements.Plan, schedule and Track project timelines and deliverables. Project management of customer projects for a wide range of generics for BA/BE and Phase I studies.Established excellent working relationships with clients across different geographic.Coordinated communication with customers and representing QPS project managementand operation team, ensuring client satisfaction and retention.Gather customer requirements and effectively communicate them to internal teams for seamless collaboration.Assist and participate in client visits, pre-qualification audits and regulatory auditsCandidate with experience from CRO Industry will be added advantage Preferred candidate profile can send to hr@qpsbioserve.com at the earliest

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 updatesCommunicate 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 servicesProactive 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

Role & responsibilities: 1. Responsible for volunteer recruitment as per requirement of the study within given time limit2. Coordinating with the volunteers for screening related activities like contacting the volunteers for screening dates, screening reports related information etc.3. Obtaining free-will and written informed consent from the volunteers for registration process and for screening procedure 4. Responsible for operation and maintenance of volunteers data bank5. Providing inputs to improve efficiency of screening process6. Ensuring compliance of the volunteers for study restrictions as per protocol7. Ensuring the volunteers comfort during conduct of the study.8. Obtaining free-will and written informed consent from the volunteers for registration process and for screening procedure in coordination with Principal Investigator / Co-Investigator / Medical Officer.9. Arrangement and distribution of compensation to volunteers10. Measuring height, weight and calculate the BMI of volunteers.11. Registration of volunteers as per the current SOPs.12. All other activities as assigned by Screening team.Preferred candidate profile: Interested male applicants with eligible qualification can send their profiles to hr@qpsbioserve.com and can also walk in to below address with profiles and academic documents. Qualification: B Sc.Languages: English, Hindi, Telugu etc.,