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Job Title: Regulatory Affairs Associate I – 1434
Location: Bangalore, India, 560064
Job Id: 50430
B. Pharm/M. Pharm/ Master of Life Sciences – M Pharm preferred
Total years of experience required for the role: 2-4 years (preferred – Regulatory Publishing experience in EU and US marke
Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate.
How you’ll spend your day
- 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
- Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems
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