Teva
Pharmaceuticals Regulatory Affairs Associate I Msc/Mpharm Apply Now
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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