Regulatory Affairs Associate I
Date: Jan 13, 2021
Location: Navi Mumbai, IN, 400706
Company: Teva Pharmaceuticals
Company Info
Job Description
- 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
Qualifications
Qualifications:
- B. Pharm/M. Pharm/ Master of Life Sciences – M Pharm preferred
Experience:
- Total years of experience required for the role: 2-4 years (preferred - Regulatory Publishing experience in EU and US market)
Knowledge and skills:
- Command over spoken and written English
- Sensitivity to the cultural diversity of a global organization
Function
Sub Function
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