8 Bioequivalence Studies Jobs

Job Title Senior Executive - Pharmacokinetics Business Unit R&D1 Regulatory Affairs Job Grade G11B Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Description Literature search and study designing of Bio...

You will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs. This includes conducting and presenting pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement. You will also predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction. Additionally, you will conduct IVIVE and IVIVC and work closely with cross-functional teams, including preclinical, clinical, and regulatory teams, to guide decision-making and project direction. Utilizing software tools such as Win...

You will be working as a Senior Executive in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac). Your primary responsibility will involve reviewing Raw Material, Packaging Material, In-process, Finished product, shelf life specification, and relevant Method of analysis. You will authorize the Testing worksheet and approve analytical data of various materials in LIMS. Additionally, you will ensure compliance with Good Laboratory Practices and review analytical method validations, transfers, and verifications. Your role will also include handling, storage, withdrawal, and reconciliation of stability samples, reviewing stability study reports, verifying outside laboratory ...

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 document...

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 evalua...

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...

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 gett...