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Require Regulatory Affairs Associate at Teva

academics

 

Clinical research courses

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.

Post : Regulatory Affairs Associate II

Job Description
• Support the life cycle management of APIs from RA perspective
• Review and approve ROS, specification and analytical control when required
• Coordinate DMF preparation, maintenance and all related activities for on time Submissions for all relevant markets
• Respond to deficiency letters and coordinate related activities
• Coordinating pre-launch activities from RA perspective
• Evaluate change requests and address the required submission per market to support the requested change. Follow through the submission
• Support customers regarding Service Requests,
• Being up-to-date with regulatory requirements, SOPs and work processes.

Candidate Profile
High degree in relevant field, e.g. chemistry / biochemistry / biology or biotechnology  Work Exp 5+ Yrs.

Additional Information
Qualification :  M.Sc
Exp : 5+ Yrs
Location : Greater Noida
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 20th January, 2020

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