Teva Pharma Associate – Regulatory Affairs, Life Sciences Apply
Teva Pharma Associate – Regulatory Affairs, Life Sciences Apply. 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 – 1434
Location: Navi Mumbai, IN, 400706
Function: Regulatory Affairs
Sub Function: Medical Regulatory Affairs
Date Posted on Company Website: May 21, 2021
Job Description:
- Publish as well as dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and also Canada.
- Exposure in handling initial submissions publishing and transmitting quality submissions to the agency.
- Perform document level publishing activities, troubleshoot document issues as well as perform quality control checks for submission-ready documents as per the agency guidance.
- Collaborate with scientific personnel for planning, prep work, publishing as well as quality control checks of submissions.
- Hands-on expertise in EU and also US submissions from pre-approval to post-approval activities like initial, variations, PSUR etc.
- Participate in Global Regulatory Affairs project.
- Maintain working knowledge of internal and also 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 yet workable and also useful solutions to difficult problems.
Qualifications:
- Master of Life Sciences preferred.
- Overall years of experience required for the role: 2-4 years (preferred – Regulatory Publishing experience in EU and US market).
- Command over spoken as well as written English.
- Sensitivity to the cultural diversity of a global organization.
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