- Manage, plan, prepare and update Quality regulatory documents which form the basis of worldwide submissions such as: clinical trials applications (from Phase I) where required, parts of license applications, applications for variations, line extensions, amendments and renewals of existing authorizations, responses to questions from the authorities.
- Manage the completion of the relevant Quality documentation platform to allow the regulatory submission in the assigned countries
- Facilitate the query handling process during the regulatory review phase on Quality issues
- May provide support at Regulatory Agencies meetings on quality issues
- Carry out regulatory review of Change Control Proposals (CCPs), study protocols and reports, as well as other relevant regulatory documents intended for the product documentation platform or to local submission. Liaise with authors and data generating functions.
- Serve as an interface between other regulatory groups and company functions as appropriate
- Ensure regulatory filing systems are maintained and up-to-date
- Perform pre-submission QC checks of Quality documentation versus the data generated at and activities performed by the manufacturing sites
- Represent Global Regulatory Affairs on GMS, SNO Project Teams and GRA Sub-Teams
- Facilitate Site Transfer Projects as regulatory representative
- Change Control Proposals > 5 yrs.
- Clinical trials applications (from Phase I) > 5 yrs.
- Quality documentation > 5 yrs.
- Regulatory Affairs > 5 yrs.
- English – business fluent, German – business fluent
Standort: Darmstadt & Remote
Projektbeginn: Mai 2019
Projektlaufzeit: Vollzeit bis 30.04.2020 (insges. 1920 Stunden); 30% vor Ort, 70% remote