Regulatory Affairs Companion Diagnostics Director

vor 2 Wochen

Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
***Director/Sr. Director Regulatory Affairs**
**Companion Diagnostics (M/F/x)**:
***Purpose of the function**:
To provide Leadership for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. To provide innovative approaches to resolve complex regulatory issues and increase speed to patients.

***Roles and Responsibilities**:
Provide critical strategic and tactical regulatory guidance for Companion Diagnostics/In-Vitro Diagnostics (CDx/IVD) development and CDx submission plan for each country/region, both before and after CDx testing:

- At the time of implementation of a CDx study/IVDR performance evaluation study & integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)
- Serve as the Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members
- Develop regulatory strategy and provide input on IVDR requirements in the EU to enable and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and Switzerland

Represent 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:

- Use of CTA/CDx within clinical trials
- Device protocols and SAPs
- Device non-significant/significant risk determinations
- Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures
- Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)
- Informed Consent Form reviews to ensure adequate disclosure for collection, retention, testing and retesting of samples

Provide device-specific regulatory insight/guidance during CDx Indication Team & Working Group (WG) cross-functional meetings:

- Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates from the drug side, as needed
- Serve as a member of the DS Alliance CDx team
- Provide RA specific inputs into CDx Risk Management plans for portfolio/individual projects/indications
- Assist the CDx team with the creation of contingency/backup plans for CDx submission
- Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorities during review of device submissions
- In collaboration with CDx lead work with Dx partners to ensure robust development of assay
- 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 (for both sponsor and partner side)

Keep abreast of the changing global regulatory environment for medical devices/IVDs and share/educate CDx department on these changes:

- Assess the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products
- Develop shared learning forums, workshops and training on new guidance, regulations to enterprise
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders. Also communicates with outside consultants (e.g. CRO) as needed

**Qualification and Requirements**:

- Degree (Bachelor, Master, State Examination, Diploma) in Pharmacy, Medicine, or Life or Natural Sciences; PhD preferred
- Working experience in Pharmaceutical Industry or Medical Device Industry, at Clinical Research Organizations or at an EU Regulatory Authority or Notified Body with at least 7-10 year experience in development of Medical Devices/Companion Diagnostics
- Experience in pharmaceutical development is a distinctive plus
- Experience in managing clinical trials in other regions is a plus
- Experience of working in global environment
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
- Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner
- Solution and detail-oriented; well organised and self-motivated
- Excellent written and oral communication skills in English, second EU language preferred

We offer an interesting, diversified and challenging position, good contractual conditi

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