Job title: Mgr Regulatory Affairs
Company: Teva Pharmaceuticals
Job description: 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!
- Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
- Collaborate with RA managers to discuss the upcoming annual report (AR) schedule and assign AR’s according to the team’s workload. Effectively communicate all assigned projects and establish submission timelines to ensure timely document requests, resulting in annual reports being compiled, finalized and submitted on time.
- Collaborate with RA managers to discuss upcoming supplements and assign supplements according to the team workload. Effectively communicate all assigned supplements, and considering the complexity of the submission, ensure the team has the appropriate understanding. RA Manager should guide the team on more complex submissions and contact internal stakeholder (when needed) to gain further insight/understanding on any given supplement. Any/all open items should be escalated to management to ensure timely resolution and alignment on approach.
- Oversee the training for respective team members on guidances, internal processes, procedures, databases and trackers.
- Oversee the performance and development of their respective team members.
- Other projects and duties as required/assigned.
- Pharm D/BS in a scientific discipline or equivalent education and related experience
- Master’s degree in RA/QA discipline, a plus.
- Minimum 8 years pharmaceutical industry experience required; 5+ years Regulatory Affairs experience required, coupled with 2 years analytical/QC, R&D/laboratory or production experience is preferred.
Medical Regulatory Affairs
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Teva’s Equal Employment Opportunity Commitment
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.
Location: Navi Mumbai, Maharashtra
Job date: Fri, 15 Apr 2022 03:07:50 GMT
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