14 Bioequivalence Jobs

Key Responsibilities Prepare, review, and submit CTD/ACTD/eCTD dossiers for international markets Develop and execute regulatory strategies for ROW, LATAM, SEA, Africa, and Pacific regions Manage product registration, renewals, variations, and post-approval compliance Ensure compliance with WHO-GMP, ICH, and country-specific regulatory guidelines Coordinate bioequivalence studies and relevant documentation Review technical files and maintain up-to-date regulatory documentation Liaise with regulatory authorities, internal departments, and external partners Mentor junior RA team members and drive process improvements Requirements B.Pharm / M.Pharm / Life Sciences background Minimum 6 years exp...

Job location: Ahmedabad Experience Required- 1+ years of experience in QA (Clinical Research) Role & responsibilities A. Review Protocol and its attachments. B. Conduct in-process and retrospective audit of clinical phase of the study to ensure compliance to protocol, SOPs and applicable regulatory requirements. C. Review Clinical report to verify that the data reported in the report, accurately reflects the raw data and to ensure that the report is prepared in compliance with SOP, ICH E3 and applicable regulatory requirements. D. Conduct system audits as per the system audit plan. E. Conduct vendor pre-qualification and re-qualification audits as per the vendor audit plan. F. Preparation, R...

Role & responsibilities End-to-end project coordination for the assigned clients with effective client interface, communication, and time delivery of the projects. Ensuring work in compliance to SOPs, processes, and requirement of Management. Feasibility, proposal development, follow-up, and finalizing of the project contract for the BE projects for the assigned clients. Coordinate & facilitate sponsor visits during in-process and retrospective study monitoring. Act as a management designee in double-blinded studies if assigned. Coordination among internal team to ensure timely delivery of projects. Publishing a project schedule to the team with appropriate tracking of milestones. Facilitate...

As a bench scientist at our organization, you will be responsible for conducting experimentation in the field of formulation research and development for global markets. Your role will involve working with scientific principles such as Quality by Design (QbD), Design of Experiments (DoE), statistics, and scale-up principles. You will be required to analyze data from literature reviews and effectively present information for decision-making purposes. Understanding the Intellectual Property (IP) scenario and working on design strategies, prior art searches, and establishing proof of concept through experiments will be a key part of your responsibilities. You will collaborate with cross-functio...

Role & responsibilities Overall responsibility of study. Conduction of study initiating meeting. ICF preparation / obtaining ICF from subject. Conducting clinical examination Review of study documents. Supervise study activities. Preparation of study reports. Communication with sponsor and IEC/IRB. To train other clinical staff. Preferred candidate profile Interested Candidate share resume on TeamHR.VAD@accutestglobal.com. Whatsapp on 9833402126

Role & responsibilities Performing as Sub-investigator in the assigned clinical studies Reviewing study documents Preparation of Clinical Raw data Protocol, SOP and various Regulatory compliance Protocol/ICF/CSR review Study initiation and Execution Pre study document preparation Dosing of the subjects Monitoring the study process Preparation of confinement report, clinical updates & clinical summary report Compilation of study documents as per protocol Review study documents and handing over to QA for review. Close the QA / Sponsors observation / queries Archival & Retrieval of study documents Subject safety follow-up Serving as QC in the assigned clinical studies Performing pharmacy activi...

Job location: Ahmedabad Experience Required- 4+ years of experience in QA (Clinical Research) Role & responsibilities A. Review Protocol and its attachments. B. Conduct in-process and retrospective audit of clinical phase of the study to ensure compliance to protocol, SOPs and applicable regulatory requirements. C. Review Clinical report to verify that the data reported in the report, accurately reflects the raw data and to ensure that the report is prepared in compliance with SOP, ICH E3 and applicable regulatory requirements. D. Conduct system audits as per the system audit plan. E. Conduct vendor pre-qualification and re-qualification audits as per the vendor audit plan. F. Preparation, R...

Job Posting Title: Senior Principal Biostatistician Reports to (Job Title) : - Group Head Biostatistics and Pharmacometrics Job Description : The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. Study level : - Key...

CPC & CCS Certification Training With Placement Life sciences Graduates only in Medical Coding Freshers * Must be certified (CPC/CCS) from AAPC or AHIMA * Strong knowledge on Human Anatomy, Physiology Offline - KPHB @Hyderabad Call - 9052442000

Key Responsibilities 1. Dossier Preparation and Submission CTD/eCTD Compilation: Assemble and submit regulatory dossiers in Common Technical Document (CTD) format, including modules for clinical, non-clinical, and quality data.

Role & responsibilities: Sample collection, dosing, separation

Role & responsibilities : Work as Pharmacokinetic and Scientific Affairs Personnel. 1. Provide feasibility inputs like study design, sample size estimation, sampling time points, wash out period, etc. 2. Review, evaluation and interpretation of PK/PD data from BA/BE studies-clinical trials and suggesting appropriate inputs in protocol and clinical study report 3. Review statistical report as per requirement. 4 Prepare and review statistical/pharmacokinetic analysis plan as per requirement 5. Archive and retrieval of data 6. Maintain and update feasibility database as per requirements 7. Maintain and assist regulatory query handling and tracking. 8. Provide impact assessment of PK related pro...

a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must.

Expertise in Ba/BE studies and Ph1;Brief CRO to an appropriate conduct of statistical analysis;Supports dossier submissions and answers statistical questions related to the file. Writes/review statistical part of protocol. Required Candidate profile Manages several projects and works in more than one therapeutic area.Appropriate statistical methodology &endpoint definitions -design of clinical studies & for associated sample size determination