Teva Pharmaceuticals Ltd Job Opening for Regulatory Affairs

Teva Pharmaceuticals Ltd Job Opening for Regulatory Affairs

Teva Pharmaceuticals Ltd Job Opening for Regulatory Affairs

Regulatory Affairs-Submission Publishing role with Teva Pharmaceuticals

Job Location: Navi Mumbai

Years of experience: 2-4

Roles & Responsibilities:

-Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.

-Exposure in handling initial submissions publishing and transmitting quality submissions to agency.

-Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.

-Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.

-Hands on expertise in EU and US submissions from pre-approval to post approval activities like initial, variations, PSUR etc.

-Participate in Global Regulatory Affairs project teams

-Maintain working knowledge of internal and external publishing standards.

-Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)

-Must be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator

If your profile matches the above requirement, please share your updated resume to pranita.padte@teva.co.in with subject line as “Regulatory Affairs – Publishing”