Teva is a global pharmaceutical leader and the worlds 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.
Post : Regulatory Affairs Associate III - 1436
• 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.
• 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.
Qualification : B.Pharm / Bachelor’s degree of Life Sciences
Location : Navi Mumbai, Maharashtra
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th June, 2022
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