Job title: Regulatory Affairs Associate I – EU Post approval
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!
- Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
- Responsibility for MA compliance with both legislation and business needs.
- Prioritize, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
- Ensure approvals are secured within the stipulated timelines for designated projects.
- Maintain registration documentation and associated electronic databases, in line with in-house procedures.
- Provide regulatory support for all internal and external customers, stakeholders and TEVA project teams.
- Professional Communication with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
- Regular status updates of the ongoing work/activities to superiors or managers.
- Maintain and develop awareness of current/pending regulatory legislation and guidelines.
Degree in science/life sciences/pharmacy or equivalent qualification(s)
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: Tue, 22 Mar 2022 05:53:03 GMT
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