Tata Consultancy Services Job opening Regulatory Affairs Specialist -apply now
About the job
TCS is hiring for “Regulatory Affairs Specialist“, details below-
Role-Regulatory Affairs Specialist
Experience- 4-8 Years
1. Responsible for preparation of Annual Report, US DSUR regional appendix, Module 1 documents.
2. Responsible for authoring of regulatory sections of the aggregate report and Annual reports.
3. Responsible for Safety report and Annual Report submission management to global countries.
4. Responsible for Post Approval Activities related to Regulatory Safety Report and Health Authority Queries.
5. Responsible for the submission operational management for all the type of applications and delivery of regulatory submissions required to support the development, registration, and compliance of products.
6. Is always up to date on new guidelines on Life Cycle Management – Regulatory scenario across US and EU countries and ROW countries.
7. Makes decisions that contribute to the resolution of moderately complex submission operational issues, with minimal guidance and support of an experienced colleagues and/or supervisor. Ensure appropriate distribution of work among direct reports.
8. Provides insights and recommendations to make or influence decisions of moderate complexity.
9. Creates and manages the Dossier Plan(s)/Submission Packages in line with regulatory strategy. Provides guidance to project team members. Seeks input from regulatory therapeutic areas, functional area representatives and key stakeholders. Ensures that all required documents are included in the Dossier/Submission Package.
10. Performs a dossier review of the published output for all the type of submissions given in the role and responsibilities.
11. Tracks submission events/activities and timelines in appropriate systems/tools.
12. Leads submission team meetings, as applicable. Works with partners to resolve issues with timelines. (e.g., with timelines, document e-sub readiness etc.).
13. Monitors the effectiveness of the dossier process to identify improvement opportunities.
14. Leads and/or participates in special projects and process improvement initiatives, as needed.
15. May create and/or sign specific submission documents.
16. Where appropriate provides component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.).
17. Utilizes current electronic document management systems/tools and/or publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions, with a high degree of independence.
18. Applies appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
19. Cultivates ongoing effective relationships within GRA as well as cross functionally. Works with partners to communicate and resolve issues/concerns with submission timelines.
20. Mentor and assist new employees.
21. Take proactive approach to be up to date with US and EU Regulatory Guidelines on post approval activities.
22. Take an active role in an industry association and share best practices with colleagues and Management.
Interested candidates can apply