MPharma Regulatory Affairs Associate Job @ Teva
MPharma Regulatory Affairs.Teva Regulatory Affairs Associate Pharma Job. Teva hiring Pharmacy candidates for the post Specialist.Teva Hiring Undergraduate Pharmaceutical Science candidates. Teva is a global pharmaceutical leader and the world’s largest generic medicines producer committed to improving health. Check out all the details on the same below:
Job Title: Regulatory Affairs Associate
Qualifications Required: B. Pharm/M. Pharm/ Master of Life Sciences.
Preferred: M Pharm
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 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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