9 Ich Requirements Jobs

Role & responsibilities Preparation and reviewing of CTD and ACTD dossier. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. Co-ordination with plant for Regulatory compliances. Timely achievement of monthly plan & timely query response. Gap Analysis/Updation of Master data. Get feedback from all the countries for respective variation, and their timely submission. Renewals. Master data Updating. Follow ups with plant for documentation regularly and review meeting Expected candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, EMA Filings, MCC South Africa for Biological and Biotech products. Has exposure to in-lice...

Site Name: Bengaluru Luxor North Tower Posted Date: Nov 19 2025 Business Introduction: At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. We're uniting science, technology, and talent to ge...

Role & responsibilities Preparation and reviewing of CTD and ACTD dossier. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. Co-ordination with plant for Regulatory compliances. Timely achievement of monthly plan & timely query response. Gap Analysis/Updation of Master data. Get feedback from all the countries for respective variation, and their timely submission. Renewals. Master data Updating. Follow ups with plant for documentation regularly and review meeting.

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and there timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW a...

Site Name: Bengaluru Luxor North Tower Posted Date: Oct 9 2025 Key Responsibilities: Performs the study set-up activities and the technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical studies. Assist with the technical & vendor oversight of multiple data types for one or more clinical studies Support the delivery of one or more Clinical studies depending upon the phase, complexity, and similarity with support of junior data acquisitions staffs as required. For studies, key responsibilities include: Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate. Coordinates review, rev...

As a Senior STEM Content Analyst with expertise in CMC Biologics, you will be a valuable addition to the Life Sciences team in India. Your primary responsibility will be to monitor regulatory changes, author detailed CMC reports, and provide support to internal teams and external customers. Collaboration with global teams, meticulous management of complex regulatory data, and contribution to product innovation will be essential for your success in this role. **Qualifications Required:** - Minimum BS degree in Life Sciences - 5+ years of experience in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs for Biologics/Biopharmaceuticals - Experience managing BLA/MAA content...

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and there timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. 11. Tracking and reviewing of document requirements of upcoming new filing in R...

Site Name: India - Karnataka - Bengaluru Posted Date: Sep 5 2025 Key Responsibilities: Performs the study set-up activities and the technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical study(ies). Assist with the technical & vendor oversight of multiple data types for one or more clinical study(ies). Support the delivery of one or more Clinical studies depending upon the phase, complexity, and similarity with support of junior data acquisitions staffs as required. For studies, key responsibilities include: Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate. Coordinates re...

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and their timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW a...