Job for Regulatory Affairs Associate at Teva Pharmaceuticals | M.Pharm, B.Pharm

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. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.

Post : Regulatory Affairs Associate I - Publishing

Job Description
• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents
• Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
• Participate in Global Regulatory Affairs project teams
• Maintain working knowledge of internal and external publishing standards
• Working knowledge of industry legislation and best practices
• Knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, paper)
• Notices when data appear wrong or incomplete, or needs verification. Distinguishes information that is not pertinent to a decision or solution.
• Compares observations or finished work to what is expected to find inconsistencies. Remains aware and takes care of details that are easy to overlook or dismiss as insignificant.
• Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems.
• Delivers products and services when and where the customer needs them. Explores options when unable to deliver a requested product or service, and pursues solutions until the customer is satisfied.
• 1-2 years in Regulatory Operations or 4-6 years in Regulatory Affairs.

Additional Information
Qualification : B.Pharm /M.Pharm, Bachelor in life sciences
Location : Navi Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 15th April, 2019