Regulatory
Affairs Associate I Teva Pharmaceuticals BSc/Bpharm
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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