Teva Regulatory Affairs Associate II - 

Mexico, State of Mexico, Ecatepec de Morelos 

350739623

To lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements.

Education: High degree in relevant field, e.g. 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 marketso 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 Continue learning of regulatory guidance, SOPs and work processes

Sr Mgr Regulatory Affairs

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