Submission Management

TCS is Hiring for Submission Management Role

Location - Mumbai / Bangalore / Pune / Hyderabad

Experience Range - 5 to 11

Preferred Educational Qualification for the role - Graduate / Postgraduate (Any life-science / Engineering)

Skill : Europe market, Regulatory guideline, eCTD, NEES, Docubridge, Validator

Job Description

• Coordinate with Regional Regulatory Lead / Product Manager, affiliate and publishing team for Submission planning of assigned product.
• Creation of Regulatory activity and Submission record, Submission Content Plan and binder for publishing.
• Assign and communicate with required stakeholders
• Match documents in Submission Content Plan and share publishing ready binder to publisher, assign and communicate for Document publishing related activities.
• Review of published output in Lorenz docuBridge tool and perform dispatch activities on Portal (EMA, CESP, UK and ZA) and to affiliates for local submission related activities.
• Update the submission events and archival of dossiers in Veeva Vault RIM.
• Update Veeva Vault RIM for regulatory correspondence and Proof of outcome.
• Strong experience in regulatory submissions in EU and ROW market
• Ability to manage end to end submission activities
• Hands on knowledge of submission lifecycle and HA responses.
• Good in communication and coordination skills with various stakeholders in the process.

Interested candidates who is having relevant Experience only, are requested share updated CV with below details on the mail id s.laharika@tcs.com

Regards

Laharika - TCS HR