
Associate Professional Regulatory Publishing
4 days ago
Provides publishing support for regulatory submissions within the life sciences industry. Includes document level and submission level publishing, archive activities, report publishing, general PDF navigation, conversion of paper documents to electronic format, and paper submissions.
- Supports electronic communication and submission processes including general correspondence, reports and amendments. Provides quality and timely deliverables to meet the client’s expectations.
- Supports end-to-end publishing services which may include lifecycle management. Works independently with mínimal supervision on common publishing tasks.
- Develops understanding and maintains knowledge of appropriate standard operating procedures (SOPs), regulations, and policies. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Provides regularly scheduled status on project metrics including hours spent, publishing efforts, etc. to the necessary project stakeholders both internally and externally.
- Builds knowledge of company and client regulatory publishing process, updates to regulatory authority guidelines, and software updates to ensure currency and compliance.
-
Senior Regulatory Affairs Publishing Manager
3 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,75,00,000 - ₹ 2,50,00,000Regulatory Affairs Professional Job DescriptionOur team seeks a skilled Regulatory Affairs Associate Senior to lead the publishing and dispatch of regulatory submissions for Devices & Drugs Submissions. Key responsibilities include:Managing and leading regulatory publishing operations globally.Ensuring submissions meet eCTD requirements and other regional...
-
Trainee - Regulatory Operations (Publishing)
3 days ago
Bengaluru, Karnataka, India ClinChoice Full timeClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Regulatory Operations Trainee on a permanent basis. You will work on projects from our varied client base,...
-
Regulatory Publishing Specialist
34 minutes ago
Bengaluru, Karnataka, India EQL Pharma AB (publ) Full time US$ 90,000 - US$ 1,20,000 per yearAbout the jobKey Responsibilities:Strong understanding of eCTD, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as: Mono eCTD, Ectd Validator, Adobe Acrobat, MS Excel, SharePoint.Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and...
-
Regulatory Operations Associate
7 days ago
Bengaluru, Karnataka, India ICON Plc Full timeRegulatory Operations Associate - Home based - Bengaluru/ Chennai/ Trivandrum ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our...
-
Publishing Specialist
2 weeks ago
Bengaluru, Karnataka, India Biocon Biologics Full timeKey Responsibilities:Strong understanding of eCTD, NeeS, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier...
-
Bengaluru, Karnataka, India AstraZeneca Full time**Job Title - Associate - International CMC Regulatory Affairs** **Career Level - C** Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get...
-
Ectd Publishing
5 days ago
Bengaluru, Karnataka, India Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Global Cmc Regulatory Associate
7 days ago
Bengaluru, Karnataka, India Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Regulatory Affairs Associate
5 hours ago
Bengaluru, India Parexel Full timeAs part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...
-
Senior Publishing Coordinator
5 days ago
Bengaluru, Karnataka, India beBeeProjectManager Full time ₹ 7,00,000 - ₹ 9,00,000Associate Project Manager RoleWe are seeking a detail-oriented and organized Associate Project Manager to oversee the publishing lifecycle from editorial and design through production and delivery.As the glue that holds projects together, you will:Orchestrate the publishing process by coordinating between internal teams and external partners.Keep timelines...