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Director Regulatory Affairs Companion Diagnostics

vor 3 Wochen

Munich, Deutschland Daiichi Sankyo Europe Vollzeit

Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. The job holder provides innovative approaches to resolve complex regulatory issues and increase speed to patients.

**Roles & Responsibilities**:

- CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan globally as well as for each country/region
- For implementation of a CDx study/IVDR performance evaluation study & integration of an assay into clinical testing and for CDx submission
- Serve as the Point of Contact for gathering country/region specific CDx RA requirements from local RA team members (e.g. from US, EU, Japan, China, Australia, Canada, Korea etc.)
- Provide regulatory expertise specifically on IVDR and corresponding regulatory requirements for use of biomarkers in clinical trials and drug/ device co-development
- CDx RA Strategy: Represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g. Diagnostic Development Teams) and to external diagnostic business partners specifically:

- Contribution to regulatory strategy to enable and support timely start of clinical trial and of registration of both therapeutic and diagnostic
- Contribution to biomarker strategies towards patient selection, patient stratification, bridging between Clinical Trial Assay /CDx assays, prospective vs retrospective analyses and collection, missing data
- Contribution to Clinical trial protocol and ICF reviews, Device study protocol development and reviews
- Project Team Participation: Provide device-specific regulatory insight/guidance in cross-functional internal and external meetings
- Represent Regulatory Affairs CDx in internal cross-functional team meetings
- Serve as member of the Joint Project Team (JPT) with the Diagnostic Partner
- Serve as a member of the Alliance CDx team as applicable
- Provide RA specific inputs into CDx as well as Regulatory Risk Management plans
- Health Authority Interactions & Submissions: Contribute to preparation of submissions and device related HA interactions
- In collaboration with CDx lead work with Dx partners to ensure alignment on CDx related HA interactions, participate in HA interaction for drug-related CDx topics/questions, and attend device company HA meetings as appropriate
- In collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to CDx for Health Authority interactions
- Contribution to preparation of Performance Study Application packages and to selection/ oversight of corresponding CRO
- Device Study Risk Determinations development and submission, IDEs
- CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate cross-functional team on these changes

**Education & Professional Experience**:

- Bachelor's Degree preferably in a scientific discipline required
- Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred
- 7 or More Years of relevant drug/ CDx co-development experience including experience within Regulatory Affairs, specifically regulatory expertise on related IVDR requirements experience of SRD/ IDE as well as PMA submissions
- Experience of drug development and drug regulatory procedures
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required
- Good interpersonal skills
- Ability to successfully lead teams and to leverage strengths of the team
- Willingness to cooperate with peers in a cross-functional environment
- Demonstrated ability to organize / prioritize tasks
- Demonstrated ability to negotiate with and influence others
- Demonstrated ability to facilitate issue resolution and conflict management

**Why work with us?**: