Teva pharmaceuticals has released a regulatory affairs job for science graduates. Candidates from Bsc, MSc, B.pharma , M.pharma may apply for this post. Find the complete details below.
Msc /M.Pharm /BSc /B.Pharm with a Scientific or Regulatory background or equivalent combination of education and experience
- 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.