Regulatory Affairs Associate I @ Teva
Pharmaceuticals , Msc/MPharm/BSc/BPharm with a Scientific or Regulatory
background
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
Msc/MPharm/BSc/BPharm
with a Scientific or Regulatory background or equivalent combination of
education and experience
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