Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
Responsibility for MA compliance with both legislation and business needs.
Prioritise, plan and monitor submission for allocated procedures while documenting and informing involved parties of progress.
To give regulatory support to project teams, stake holders and European Units for defined product responsibilities.
Support the development and implementation of regulatory strategies for defined projects.
Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
Maintain and develop awareness of current/pending regulatory legislation and guidelines.
Support the defined processes within the department and provide input where improvements can be made.
Awareness of current/pending regulatory legislation and guidelines
Your experience and qualifications
Required Degree/Master in Pharmacy or Master in science/life sciences
Relevant years of experience required for the role: 4 to 6 years in Regulatory affairs with EU post approval
Overall Pharma industry experience: 4 to 6 years
Desirable to have EU member state experience and knowledge of European regulatory procedures.