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
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
Requirements:
Good human communications High service approach to internal external customers
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
Good human communications High service approach to internal external customers
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
Education
High degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnology
This position is open to all candidates.
