Teva pharmaceuticals hiring for Regulatory Affairs Associate. Interested candidates may apply as mentioned below.
Job Information:
1. Department: Regulatory Affairs
2. Designation: Associate
3. Qualification: B.Sc/ M.Sc/ B.Pharm/ M.Pharm
4. Experience: 1 – 3 years
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.
👉 Works 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 ina a team environment with moderate supervision.
👉 Performs all other job related duties as required by management.
👉 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.
👉 Works 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 ina a team environment with moderate supervision.
👉 Performs all other job related duties as required by management.
Important Details:
1. Work Location: Navi Mumbai
2. Opening Date: 18/05/2020
