Teva is a global pharmaceutical leader Vacancy for Regulatory Affairs Associate I B. Pharm/M. Pharm/ Master of Life Sciences
Date: Dec 16, 2019
Location: Navi Mumbai, IN, 400706
Company: Teva Pharmaceuticals
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!
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.
Qualifications
B. Pharm/M. Pharm/ Master of Life Sciences.
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