Teva Regulatory Affairs Associate II 

India, Maharashtra, Navi Mumbai 

842688757

• 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 development of content of labeling, side-by-side comparisons, SPL update 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 minimum supervision.
• Assists the Group leader in the assignments and review of labeling documents.
• Performs all other job-related duties as required by management.

Qualifications:

• M.Sc./M Pharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience.

• Total years of experience required for the role: - 4 plus years US Labelingexperience.
• Relevant years of experience: 4 plus years (Pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling

Individual must:

• Be able to multi-task in a fast-paced workenvironment.
• Have exemplary oral and written communicationskills.
• Be organized with a keen attention todetail.
• Have the ability to work independently as well as in a team environment with minimumsupervision.
• Have knowledge of FDA US regulations and guidance's related to US Gxlabeling.
• Have knowledge of FDA eCTD submission standards and experience in applying these requirements to routine labeling submissionssubmitted.

Specialized or Technical Knowledge

• PC, Microsoft Office Suite with a proficiency in Microsoft Word
• Adobe Acrobat Professional is amust.
• Familiarity with TVT preferred.

Manager - Regulatory Affairs