Teva Regulatory Affairs Associate Pharma Job Opening 2020
Teva Regulatory Affairs Associate Teva Regulatory affairs Job Pharma Job. Teva hiring BPharma candidates for the post.Teva Hiring Undergraduate and Postgraduate Pharmacy candidates. Teva is a global pharmaceutical leader and the world’s largest generic medicines producer committed to improving health. Check out all the details.
Job Title: Regulatory Affairs Associate
Qualifications
B. Pharm/M. Pharm/ Master of Life Sciences.
Required:
2-4 years in Regulatory Operations/Regulatory Affairs
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 the 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 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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