5 Bioequivalence Studies Jobs

Job Summary: We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations . The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada . This role also involves overseeing clinical trials as a Sponsors Representative , managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and documentation. Key Responsibilities: BE/BA & Regulatory Focus: Design and oversee Bioequivalence and Bioavailability studies across various dosage forms. Ensure strict compliance with regulatory standards (USFDA, Health Canada, WHO). Develop and review study protocols, SOPs, ICFs, and Clinical Study Reports (CSRs). Coordinate with CROs, bioanalytical labs, and internal teams for timely project execution. Interact with regulatory agencies and provide scientific responses to queries/deficiencies. Monitor regulatory trends and update internal SOPs and processes accordingly. Clinical Study Operations: Serve as Sponsors representative in assigned clinical studies, ensuring ethical and procedural compliance. Oversee dosing of study subjects , subject safety follow-ups , and ensure adherence to ICH-GCP. Review and compile raw clinical data, ensure proper monitoring and quality control (QC) . Prepare clinical updates , confinement reports , clinical summary reports , and ensure accuracy of clinical documentation. Review and finalize study documents, then hand over to QA for further processing. Support in EC submissions of protocols and related documentation. Manage study initiation , execution , archival , and retrieval of clinical records. Address and close QA/Sponsor queries and observations. Required Skills & Competencies: Deep understanding of ICH-GCP and regulatory guidelines (USFDA, CDSCO, Health Canada, WHO). Strong background in pharmacokinetics, clinical study design, and regulatory documentation. Ability to perform both strategic planning and hands-on clinical trial execution. Proficiency in clinical data handling, document management, and compliance tracking. Preferred Candidate Profile: Strong interpersonal skills and leadership qualities. Exposure to complex generics and/or challenging dosage forms is an advantage. Educational Qualifications: B.Pharm , M.Pharm , and Ph.D. in Pharmaceutical Sciences, Clinical Research, or a related field

We are seeking a dynamic and experienced Specialist in Formulation Development team to develop the product formulation, ensure successful pilot & pivotal bio study, scale-up and exhibit, respond to deficiencies with proper justification. Ensure successful development of robust stable formula and process for given product from bench scale to commercial level. Roles & Responsibilities You will be responsible to Review and analyse data, collaborating with the Strategy design team to prioritize product criticality and plan preformulation studies. Coordinate with the preformulation team to strategize reverse engineering studies for comprehensive characterization. You will be responsible to evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase. You will be responsible to strategize and oversee product development, ensuring timely milestone achievements and effective formulation experiments. Coordinate daily analysis plans with the Analytical team, proactively addressing potential challenges and ensuring resource availability. Facilitate pilot and exhibit batch processes, collaborate on process optimization trials, and contribute to PDR and filing preparation for the development of a robust and stable bioequivalent drug product. You will be responsible to perform and review experiment documentation as per company systems (ELN). Write Batch plans, protocols, sampling plans etc. You will be responsible to ensure robust regulatory strategy for drug products by preparing effective and comprehensive response to regulatory queries related to formulation development. You will be responsible to facilitate laboratory and equipment maintenance and implementation of company safety standards by Preparing and reviewing Standard Operating Procedure (SOP) pertaining to the function. You will be responsible to provide guidance to develop formulation capabilities within team. Qualifications Educational qualification: Masters/Ph.D in pharma Minimum work experience: 7 years of experience in Formulation development Skills & attributes: Technical Skills Experience in end-to-end product development and troubleshooting. Developed Oral Solid dosage forms and delivered 3-4 products overall for regulated markets. Good theoretical and practical understanding of different stages of formulation research and development Demonstrates theoretical knowledge of commonly used analytical evaluation and characterization tools. Basic understanding of engineering principles & process controls related to equipment and process scale ups. Knowledge of agency requirement like Food Drug Approval (FDA) guidelines; Current Good Manufacturing process (cGMP), Current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs). Complete understanding on prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects. BehavioralSkills Excellent communication and interpersonal skills. Business Acumen & Decision Making Strong analytical and problem-solving abilities. Performance oriented and good at building, leveraging relationship. Ability to work collaboratively with own team and cross-functional teams. Committed to Learning & Coaching the team.

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 activities. EC submission of protocols and related activities Preferred candidate profile Knowledge of ICH - GCP Knowledge in Regulatory guidelines like CDSCO, USFDA, EMEA, WHO etc., Communication skills

Role & responsibilities: Preferred candidate profile :

Role & responsibilities Reviewing of documents received from Project Managers and then preparing and filling of dossiers for BE NOC/CT NOC/GCT/biosimilar Clinical trial as per New Drugs and Clinical trials rules 2019. Reviewing, preparing and filling of dossiers seeking Import License for Investigational Products for bio-studies/Clinical Trials for DCG(I) submission as per New Drugs and Clinical trials rules 2019. Export of biological samples of biostudies/Clinical Trials done in India for DCGI approval. Reviewing, preparing and filling of dossiers seeking approval from ICMR, New Delhi for import of biological samples for analysis purpose Reviewing, preparing and filling of dossiers for getting Import Certificate from Central Bureau of Narcotics, Gwalior for Narcotic and Psychotic drugs. Reviewing, preparing and submissions of SUSAR/SAE notifications as well as Annual progress reports of Global Phase II oncology Clinical Trials/regular bio-studies. Coordinating with Consultant at Delhi pertaining to DCGI Office/ICMR related submissions and approvals. Advise to Business Development team/Project Management Team and other concerned personnel pertaining regulatory related issues and also providing updates regarding changes done in the guidelines, notifications, amendment etc. time to time. Maintaining of the records of each application/ notification/ amendment /etc. and regulatory related documents. On weekly basis update regulatory application status file and forward the same to management/Project Managers/etc. Forward inward copy or approval copy to respective Project Managers. Coordinating and assisting to management and departmental Heads for regulatory related matters. Dissemination of information/news/updates related to Indian Regulation within company. Responsible for team development by mentoring and training. Responsible for approval of individual employees performance goals. Ensure the safety and well-being of departmental employees and provide assistance to resolve employee grievances. Support and help resolve inter and intra departmental issues for achieving organizational objectives. Responsible to manage departmental work in absence of reporting manager. Responsible to approve leaves and attendance of team member. Reward and Appreciate employees to boost their morale Keep a check on departmental attrition and make efforts in reducing the same. Responsible to manage departmental work in absence of reporting manager. Any other task given by reporting authority.