bla

Position:  Lead Regulatory BLA and IND ExpertJob Type: CONSULTANTLocation: The role is based in Mumbai, with frequent travel to the US required. Candidates with a valid US VISA will be given preference.Job Summary: -The Lead Regulatory BLA and IND Expert will be responsible for leading the regulatory strategy and submission process for...

Oncology Clinical Researcher (AI Training) About The Role What if your deep expertise in cancer clinical trials could directly shape how AI understands and reasons about oncology — influencing research that affects millions of patients worldwide? We're looking for Oncology Clinical Researchers to bring real-world clinical rigor into cutting-edge AI...

Overview Principal Statistical Programmer Be Part of One Team, One Purpose. At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy,...

Overview: Principal Statistical Programmer Be Part of One Team, One Purpose. At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy,...

𝗧𝗵𝗶𝘀 𝗿𝗼𝗹𝗲 𝗶𝘀 𝗳𝗼𝗿 𝗼𝗻𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗪𝗲𝗲𝗸𝗱𝗮𝘆'𝘀 𝗰𝗹𝗶𝗲𝗻𝘁𝘀 𝗦𝗮𝗹𝗮𝗿𝘆 𝗿𝗮𝗻𝗴𝗲: 𝗥𝘀 𝟰𝟬𝟬𝟬𝟬𝟬𝟬 - 𝗥𝘀 𝟲𝟬𝟬𝟬𝟬𝟬𝟬 (𝗶𝗲 𝗜𝗡𝗥 𝟰𝟬-𝟲𝟬 𝗟𝗣𝗔) Experience: 14+...

Title: Associate Director, Biostatistics Business Unit: Global Clinical Development Job Grade: DGM Location: Remote/Hybrid 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...

Job Title: Medical Director, Patient Safety PhysicianGCL : FIntroduction to role:Are you ready to set the clinical safety strategy that safeguards patients while accelerating transformative medicines? This role puts you at the center of benefit-risk decisions for high-impact therapies, guiding products from development through post-marketing with clarity,...

Overview: Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding...

Job Description: JOB RESPONSIBILITIES Major purpose of the Job : •Define and execute regulatory strategies for pre and post-approval supplements for US market. •Drive regulatory strategies and ensure timely approvals to support business objectives. •Handling of regulatory Labelling/artwork review and submission. •Mentor the team in submission...

Job Title Associate Manager/ Manager – Regulatory Affairs (CMC – Drug Substance) Function Global Regulatory Affairs – CMC Location Bangalore, India Role Purpose The role supports development, registration, and lifecycle management of CMC activities for biologics/biosimilars. The incumbent will work closely with senior regulatory colleagues and...

Overview Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding...

Assistant Manager – Regulatory Affairs (Biologics / Biosimilars) Location: Ahmedabad Qualification: M.Pharm / M.Sc. / Ph.D. in Biotechnology, Biochemistry, Life Sciences, or related discipline Experience: 3-10 years in Regulatory Affairs for Biologics/Biosimilars About the Role We are seeking a highly motivated Regulatory Affairs professional to support...

Job Summary : - Lead regulatory strategy and execution for biosimilar BLAs/MAAs with primary ownership of Module 3 (CMC) and Module 5 (clinical). Partner cross-functionally (Process/Analytical Development, Quality, Clinical, PV, Supply Chain) to ensure high-quality dossiers, timely health-authority interactions, and successful approvals and lifecycle...

Regulatory CMC– Biosimilar/BiologicsDescriptionWe are looking for amazing candidates with at least 10 years of Regulatory CMC strategy experience who can lead or support biologics projects for successful outcomes with regulators. Ideal candidates will have acquired the end-to-end knowledge and line-of-sight needed to facilitate a smooth path to licensure...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

About HireRight HireRight is the premier global background screening and workforce solutions provider. We bring clarity and confidence to vetting and hiring decisions through integrated, tailored solutions, driving a higher standard of accuracy in everything we do. Combining in-house talent, personalized services, and proprietary technology, we...

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

Title: SME, CDISC & eSubmission Standards Business Unit: Global Clinical Development Job Grade: Manager, G10 Location: Hybrid/Remote 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...