Teva Pharma Vacancies for Life Sciences – Regulatory Affairs Associate
Teva Pharma Vacancies for Life Sciences – Regulatory Affairs Associate. Life Science Regulatory Affairs Associate Job Openings. Regulatory Affairs Associate Vacancies at Teva Pharma. Interested and eligible applicants can check out all of the details no the same below:
Name of Job: Regulatory Affairs Associate I
Location: Navi Mumbai, IN, 400706
Function: Regulatory Affairs
Sub Function: Medical Regulatory Affairs
- Publish and dispatch major and also complex routine/lifecycle management eCTD submission projects for EU, the US as well as 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 according to the agency guidance.
- Collaborate with scientific personnel for planning, prep work, publishing and also quality control checks of submissions.
- Hands-on expertise in EU and United States 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 also eCTD associated specification/guidelines governing regulatory submissions (eCTD, NeeS, paper).
- Should 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: Master of Life Sciences
- Complete years of experience required for the role: 3-6 years with Regulatory Publishing experience in EU and also the United States market.
Knowledge and also abilities:
- Command over spoken and written English.
- Sensitivity to the cultural diversity of a global organization.
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