To lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements.
The position is temporary for 6 months, with the option to extend permanently.
Duties and Responsibilities:
Support the life cycle management of APIs from RA perspective and resolve difficulties rose during development, review and commercialization periods
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
Identify new trends in deficiency letters received and work to prevent them in future submissions.
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
Proactively suggest and support development/improvement of RA work processes in order to achieve constant improvement of our department
Train new RA associate on specific subjects when asked to
Guide RA department on relevant subjects
Master degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnology - must
PhD in relevant field - advantage
Good communication skills, high service approach to internal & external customers
Good Leadership and communication skills
Self- learning capabilities
High level writing skills
Time management and meeting work target time lines abilities
Self-motivated and initiative
Good professional English level, both in writing and speaking