1. Department: Regulatory Affairs
2. Designation: Associate
3. Qualification: B.Sc/ M.Sc/ B.Pharm/ M.Pharm
4. Experience: 1 – 3 years
👉 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.