Pharma Regulatory Affairs Associate Post Vacancy 2022 @ Teva
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.
Job Title: Regulatory Affairs Associate I
Qualifications
Msc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience
Function Regulatory Affairs
Sub Function Medical Regulatory Affairs
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 the development of the 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 like RLD updates, Safety labeling changes, Annual reportable changes, Electronic Medication Guide initiatives, etc., and any other projects as per requirement 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.
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