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Regulatory Affairs Associate III – 1436
Date: Jun 1, 2022
Location: Navi Mumbai, IN, 400706
Company: Teva Pharmaceuticals
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
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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
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Working closely with management, initiate regulatory strategy on CMC issues throughout the drug development process, submission as well as readiness for product launch
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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
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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
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Keep current with the Teva work procedures, Health Canada Regulations/ Guidances as well as ICH regulations
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Ensures compliance with all Company policies and procedures, including safety rules and regulations
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Other projects and duties as required/assigned
Qualifications
Education
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.
Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on “Employee Central”. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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
