Regulatory Affairs Associate

Qualification:

B. Pharm/M. Pharm/ Master of Life Sciences

Experience:

2-4 years of relevant experience in Regulatory Publishing preferably in EU and US market

General Duties & Responsibilities: Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada. Exposure in handling post approval 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 and publishing. Maintain working knowledge of internal and external publishing standards. Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper) Must be aware of Technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

Interested candidates can share their CV to