Director Regulatory Affairs Companion Diagnostics (CDx) (m/f/x)

Hiring By - Biostaffic



Job Highlights

Not Disclosed

Posted 4 months ago
Job details
Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
We are seeking highly qualified candidates to fill the position:
Director Regulatory Affairs Companion Diagnostics (CDx) (m/f/x) The Position
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?
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
For more information:

What we offer

  • Excellent Benefits
  • Work-Life-Balance
  • Growth and Development
  • Health and Wellbeing Support

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • Germany

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Daiichi Sankyo Europe GmbH
Daiichi Sankyo Europe GmbH

Current Openings: 0

Daiichi Sankyo is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people around the world by leveraging our world-class science and technology. In Europe, we want to become the benchmark for customer centricity in the areas we work in and a competitive player in Oncology. For these reasons we are constantly looking for new talents that are willing to deliver the best solutions to the various healthcare professionals who aim to provide their patients with the best possible therapy - whether in the cardiovascular or oncological field. We know that our success in Europe relies on courageous people who seize opportunities and turn them into results. This is why we encourage our teams across Europe to be passionate about their objectives, challenge conventional thinking and share their local recipes for success and learnings with the whole company. It is only through their input, ideas and honest feedback that we can learn and leverage the full potential of our company. In Europe we are operating in 13 countries. Because of our rather small size compared to larger pharmaceutical companies, each of our employees can have a huge impact – whether they work in the medical area, sales force, business intelligence or the IT department. This is why everybody at Daiichi Sankyo rolls up their sleeves and gets things done, even if this means that they sometimes have to go beyond their usual duties. If you would like to be an active member of our European family, we highly appreciate your application. Please take a look at our current vacancies. Imprint: All information posted by Daiichi Sankyo Europe on this channel is intended for non-US, non-Canada & non-UK visitors.
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