Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA’s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers
Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufacturing site transfers & new registration submissions word wide (as per health authority requirements).
For new submissions - Represents Regulatory Affairs LCM BOE team in in NTO project team meetings, RA global and regional team meetings.
Organize regulatory readiness with relevant line functions and with Country Organizations & Regions for timely delivery of submission and approvals
Track progress of assigned projects, including timelines and dossier deliveries.
Ensure quality and compliance with global regulatory requirements, countries requirements and adherence to regulatory internal policies and processes
Support for maintaining country requirement lists and conducting need-based surveys & interaction with country organizations.
Contribute to non-project related initiatives and excellence activities
Support lessons learned sessions and trainings within and external to RA GDD leading to improve strategies and decisions on common regulatory approaches.
Qualifications
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Minimum of 3-5 years of experience in Regulatory Affairs, related areas of the pharmaceutical Industry
Good interpersonal and communication skills
Ability to plan and prioritize work
Ability to work effectively in a matrix environment
