Coordinator Regulatory Submission

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

Key Responsibilities Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements. Review technical documents from manufacturing sites, including: Specifications Batch Manufacturing Records Process & Analytical Validations Batch Analysis Data Stability Data Compile initial dossiers (Modules 2 & 3)...

Job Title: Study Start-up and Regulatory Submission ManagerLocation: Navi Mumbai, IndiaExperience Required: 5 10 yearsEmployment Type: Full-TimeWorking Days: 2nd & 4th Saturdays; All Sundays OffJob DescriptionWe are seeking an experienced Study Start-up and Regulatory Submission Manager to join our clinical operations team in Navi Mumbai. The ideal candidate...

Job Description:">The Regulatory Affairs Coordinator plays a crucial role in ensuring compliance with regulatory requirements for assigned projects. The role involves the collation, compilation, and timely dispatch of required regulatory documentation to affiliates/customers and follow-up on timely submission of applications to the health...

Job Summary: We are currently seeking a **full-time, office-based** Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your...

_**Looking for Freelancers**_ **Position**: Freelance Field Document Submission Staff **Type**: Freelance (Part Time) **About the Role**: **Key Responsibilities**: **Submission Coordination**: - Submit documents to Educational institutions including Universities, colleges, and boards. - Track submission statuses and follow-ups. **Communication**: -...

Knowledge of ICH guidelines, CTD dossiers. - Assist in preparing and compiling necessary documents for regulatory submissions. - Coordination with manufacturer for collecting documents for preparation of dossier, review of dossier and submission to respective regulatory authority - Coordinate with the manufacturer to gather necessary information for...

RESPONSIBILITIESBook-in, Data Entry and Quality Reviewer of ICSR in Argus databaseICSR Global Submission (Timelines and Submission Process)Vendor ManagementSOP training in department as and when neededDESIRED SKILLSGood knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines.Good knowledge about timelines and submission process of...

**Description** Associate RA ( Module 1, regulatory submission) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the...

Job Title: Senior Executive - Regulatory Affairs UK/IE/MT Department: Regulatory Affairs Grade Level: P-2 Reports to: Manager / Sr. Manager - Regulatory Affairs Number of Reports: NONE Location: Mumbai **Main purpose of role**: To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio...