Teva Regulatory Affairs Associate - Maternity leave replacement 

Israel, Center District 

137407607

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

• Support the life cycle management of APIs from RA perspective
• Review and approve ROS, specification and analytical control when required
• Coordinate DMF preparation and related activities for On Time Submissions for all relevant markets
• Proactively collaborates with the Regulatory Specialist team members, which support the submission or answer service requests
• 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
• Respond to deficiency letters and coordinate related activities
• Coordinating pre-launch activities from RA perspective
• Manages the regulatory aspects and related tasks of the assigned commercial APIs
• Evaluate change requests and address the required submission per market to support the requested change. Follow through the submission
• Maintain up to date the DMFs according to the required regulation of updating per market.
• Support customers regarding Service Requests, giving relevant professional information in the shortest of time
• Continue learning of regulatory guidance, SOPs and work processes

Good Leadership and communication skills
Organized
Wide and open view
Self- learning capabilities
Individual work ability
Comprehensive work
High writing skills
Meeting work target time lines
Accuracy
Readiness to work when requiredInitiative
Self-motivated
Time management
English good professional level, both in writing and speaking

High degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnology

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