Teva Pharmaceuticals Regulatory Affairs Associate I BSc/Bpharm
Msc/Mpharm
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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