REGULATORY AFFAIRS ASSOCIATE II - JOB DETAILS | TEVA PHARMACEUTICALS

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives.
It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.
Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.
Today, at least 200 million people around the world take one of our medicines every single day.
An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity To lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements.
Your experience and qualifications Education.
High degree in relevant field, e.
.
chemistry/biochemistry/biology or biotechnology Conversational English and at least 5 years of experience according minimum requeriments below.
o    Support the life cycle management of APIs from RA perspective  o    Review and approve ROS, specification and analytical control when required o    Coordinate DMF preparation and related activities for On Time Submissions for all relevant markets o    Proactively collaborates with the Regulatory Specialist team members, which support the submission or answer service requests o    Prepare a DMF specific high level gap analysis report and proactively communicate any risk to the relevant departments.
Follow up on the gaps' solving during the review period  o    Respond to deficiency letters and coordinate related activities o    Coordinating pre-launch activities from RA perspective o    Manages the regulatory aspects and related tasks of the assigned commercial APIs  o    Evaluate change requests and address the required submission per market to support the requested change.
Follow through the submission o    Maintain up to date the DMFs according to the required regulation of updating per market.
o    Support customers regarding Service Requests, giving relevant professional information in the shortest of time o    Continue learning of regulatory guidance, SOPs and work processes Make a difference with Teva Pharmaceuticals Reports To Sr Mgr Regulatory Affairs   Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central".
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