Regulatory Affairs Associate III – 1436
Date: Jun 1, 2022
Location: Navi Mumbai, IN, 400706
Company: Teva Pharmaceuticals
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!
Perform all regulatory activities for assigned projects including review, dossier compilation, quality file preparation, as well as preparation of responses to Health Canada’s deficiency letters in cooperation with other business functions
Working closely with management, initiate regulatory strategy on CMC issues throughout the drug development process, submission as well as readiness for product launch
Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
Responsible for evaluating change controls for regulatory filing assessments in accordance to guidance documents. Subsequently prepare and ensure timely post approval regulatory activities, as applicable
Keep current with the Teva work procedures, Health Canada Regulations/ Guidances as well as ICH regulations
Ensures compliance with all Company policies and procedures, including safety rules and regulations
Other projects and duties as required/assigned
Bachelor’s degree in a scientific discipline, preferably in life sciences. B.Pharm is a plus.
Master’s degree in a scientific discipline, preferably in life sciences. M.Pharm or MS in RA is a plus.
Work Experience :
8 to 10 years in the pharmaceutical industry in RA, R&D, Analytical RD or Quality with 6+ years in Regulatory Affairs (CMC) with a strong background in the generic pharmaceutical industry. Experience of regulatory submissions and deficiency responses to Health Canada a distinct advantage.
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.
EOE including disability/veteran