Regulatory Affairs Associate Job Vacancy Teva – Apply Online
Teva invites postgraduate and undergraduate B Pharma & M Pharma candidates for the post of Associate. MPharma & B Pharma job opening at Teva. MSc & Pharma job opening 2020. Interested and eligible candidates may apply. Check out all the details
Job Title: Regulatory Affairs Associate
Qualifications
1- 2yrs Msc/MPharm
2-3yrs BSc/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience.
Job Description
- Develop labelling 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 labelling documents needed for full responses to FDA via appropriate filing mode. This includes but is not limited to development of the content of labelling, side-by-side comparisons and other required submission materials, as necessary.
- Work within the team to proofread established labelling 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 labelling.
- Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labelling.
- Work in a team environment with moderate supervision.
- Performs all other job-related duties as required by management.
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