Global Regulatory Study Lead

vor 23 Stunden

Bern, Schweiz CSL Behring Vollzeit

In this challenging and important role you will be expected to:
**1) Lead CTA activities for global clinical trials during the entire study lifecycle**
- Develop the CTA submission strategy for clinical trials
- 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 communication / interactions
- Liaise with other GRA functions as well as with key functions within Clinical Research and Development, Clinical Operations, Global Clinical Safety & Pharmacovigilance, Clinical Trial Supply, pre-Clinical, Legal Affairs and CRO and organize the timely and effective generation of CTA documents to ensure CTA submission is performed on time and with high quality documents
- Contribute to or review key documents such as, but not limited to CSP, IB, IMPD, IMP labels, DSUR
- Prepare and approve core CTA dossier
- Oversee preparation of country-specific CTA dossiers and ensure consistency with core CTA dossier
- Manage interactions between Health Authorities and CSL by leading the response to any questions in regards to CTA
- Disseminate the CTA project status like CTA submission, CTA approval, CA questions to the concerned stakeholders
- Ensure accurate and timely tracking and archiving of CTA activities in the CSL systems
**2) Maintain and improve CTA processes related to CTA activities. Contribute to development and improvement of systems and solutions related to CTA activities**:

- Maintain and improve processes, procedures and systems which support the global management of CTAs
- Share lessons learned within the team
- Management and oversight of First Service Provider (FSP) and Contract Research Organizations (CROs) performing CTAs to ensure quality, timely approvals, and compliance. Ensuring synergies/lessons learned are used to improve CTA approval processes and timelines.
- Lead CTA regulatory meetings as per the standard operating procedure.
- Plan and prepare CTA-related SOPs and working practices; provide inputs in the regional CTA working instructions
- Be a member of the Global Regulatory Strategy Team (GRAST) and the Study Execution Team (SET) and participate in its meetings.
**3) Act as the primary point of contact for stakeholders outside of GRA for CTA specific information**:

- 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
- Maintain a CTA knowledge database with up to date information on ongoing and past clinical trials (e.g. countries benchmarking, list of questions, submission requirements, etc.)
- Ensure standard processes, tools and procedures are used consistently for CTA process
**4) Manage collection of in-house benchmarking information, tracking of regulatory CTA metrics and KPIs for key activities to ensure continued process improvement**

**Experience**:

- 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
- Experience in scientific/medical research
- Demonstrated sound judgment and flexible approach to managing situations
- Customer service focus

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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