Teva Pharmaceutical hiring for Regulatory Affairs Associate I - Publishing
Teva Pharmaceutical hiring B. Pharm/M. Pharm/ Master of Life Sciences for Regulatory Affairs Associate I - Publishing. Please check for below job description.
Company Info
Hands on expertise in EU submissions from pre-approval to post approval activities like initial, variations, PSUR, etc.
Teva Pharmaceutical hiring B. Pharm/M. Pharm/ Master of Life Sciences for Regulatory Affairs Associate I - Publishing. Please check for below job description.
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| Teva Pharmaceutical hiring B. Pharm/M. Pharm/ Master of Life Sciences for Regulatory Affairs Associate I - Publishing |
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer committed to improving health and increasing access to quality Health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development, and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Location: Navi Mumbai,
Company: Teva Pharmaceuticals
Eligibility Criteria:
Required:
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B. Pharm/M. Pharm/ Master of Life Sciences.
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Preferred:
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M Pharm
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Required:
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2-4 years in Regulatory Operations/Regulatory Affairs
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Preferred:
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Regulatory Publishing experience in EU and US markets.
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Salary:-Not Disclosed by Recruiter.
No. Of Vacancies: Not Disclosed by Recruiter
Job Description
Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for the 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.
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. It generates unique but workable and useful solutions to difficult problems.
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