Teva Pharmaceuticals Regulatory Affairs Associate I BSc/B.Pharm
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
Develop labeling documents to ensure alignment with the
Reference Listing Drug. This includes
QC, proofing, editing and formatting of documents, and coordinating the review
and approval of final submission documents with US Labeling Team members.
Create, revise, and prepare labeling documents needed for
full responses to FDA via appropriate filing mode. This includes but is not
limited to develpment of content of labeling, side-by-side comparisons and
other required submission materials, as necessary.
Work within the team to proofread established labeling files
for content accuracy either manually or by utilizing the electronic
proofreading tool TVT.
Work with US Regulatory Labeling Team to ensure assigned
projects are submitted on-time following the eCTD requirements related to
labeling.
Maintain knowledge of US regulations, guidelines, and
standard operating procedures applicable to US Gx labeling.
Work in a team environment with moderate supervision.
Performs all other job related duties as required by
management.
Qualifications
1- 2yrs Msc/MPharm
2-3yrs BSc/BPharm with a Scientific or Regulatory background
or equivalent combination of education and experience.
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