Regulatory Affairs Associate I

Company Info

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. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
• Exposure in handling initial submissions publishing and transmitting quality submissions to agency.
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
• Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
• Hands on expertise in EU and US submissions from pre-approval to post approval activities like initial, variations, PSUR etc.
• Participate in Global Regulatory Affairs project teams
• Maintain working knowledge of internal and external publishing standards.
• Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
• Must be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator
• Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems

Qualifications

Qualifications:

• B. Pharm/M. Pharm/ Master of Life Sciences – M Pharm preferred

Experience:

• Total years of experience required for the role:  2-4 years (preferred - Regulatory Publishing experience in EU and US market)

Knowledge and skills:

• Command over spoken and written English
• Sensitivity to the cultural diversity of a global organization

Function

Sub Function

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.