CSL Behring the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions.
For our location in Bern, we are looking for a
Global Regulatory Study Lead
Main Responsibilities and Accountabilities :
Lead regulatory Clinical Trial Authorization (CTA) activities for global clinical trials during the entire study lifecycle :
Develop the CTA submission strategy for clinical trials and ensure CTA submissions are being performed on time with high quality documents.
Act as an accountable interface regarding regulatory CTA topics within Regulatory and between Regulatory and other key functions, and providing strategic input.
Prepare, compile and submit country-specific CTA dossiers in selected countries and act as single point of contact for authority / interactions.
Contribute to or review key study documents (e.g. study protocol, IB, IMPD, DSUR).
Prepare and approve core CTA dossier, oversee preparation of country-specific CTA dossiers and ensure consistency with core dossier.
Manage interactions with authorities by leading the response to any CA questions related to CTA.
Oversee CTA outsourcing to CRO by :
Providing regulatory project management of CTA activities and approving CTA documents.
Ensuring synergies / lessons learned are used to improve CTA approval processes and timelines.
Providing input in CRO selection process and in clinical study budget for CTA activities.
Act as Subject Matter Expert for CTA-related topics :
Keep abreast of new CTA requirements, regulations and guidance documents.
Ensure CTA Operations readiness for the implementation of new CTA regulations, e.g. EU CTR.
Manage collection of in-house benchmarking information, tracking of regulatory CTA metrics and KPIs for key activities to ensure continued process improvement.
Maintain and improve processes, procedures and systems which support the global management of CTAs.
Lead the Regulatory Execution Team (RET).
Be a member of the Global Regulatory Strategy Team (GRAST) and the Study Execution Team (SET) .
This position belongs to a team of 4 GRSL located in Switzerland & Germany and has no direct report.
Qualifications & Experience :
A degree (BSc / MSc or equivalent in life science, pharmacy, medical laboratory technology or other health / medical related area preferred).
As a guide, a minimum of 5+ years’ experience in managing Clinical Trial Authorizations.
Broad knowledge of regulatory requirements in key markets for obtaining Clinical Trial Authorizations.
Extensive and comprehensive knowledge of ICH guidelines / GCP and current medical / scientific / regulatory knowledge.
Experienced in working within a Matrix, multi-cultural and global Environment
Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
Demonstrated ability to problem solving and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
Excellent written and oral communication skills in English German skills are a plus.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and / or diplomas in the original language.
Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.