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