Teva Pharmaceuticals Recruitment July 2020 Msc/MPharm/Bsc/BPharm for Regulatory Affairs Associate I @ Navi Mumbai, IN . Interested candidates may apply online for selection as detailed below.
Important Vacancy details:
- Post Name: Regulatory Affairs Associate I
- Education :Msc/MPharm/Bsc/BPharm
- Experienced:2 to 4 years
- Location: Navi Mumbai, IN
- Salary : NA
- Openings :NA
Job Description: We have requirement for the post of Regulatory Affairs Associate I in Teva Pharmaceuticals
- 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.
Selection Process: The selection will be on the basis of Interview.