Job type: Full-time

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Janssen a Pharmaceutical Company of Johnson & Johnson, is recruiting for a Global Regulatory Leader for our Diagnostics, Digital, and Data Sciences portfolio within the Pulmonary Hypertension (PH) Therapeutic area. The position will be based at Allschwill, Switzerland.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

Janssen is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled, and intravenous medications.

Global Regulatory Leader

This job opening is for a Global Regulatory Leader working in the development of novel and exciting diagnostics tools (i.e., digital health, artificial intelligence algorithms, machine learning, blood and breath-based biomarker, therapeutic devices, etc.) and linking them with the PH portfolio of drug treatments. Specific regulatory expertise in diagnostics and a solid understanding of pharmaceutical regulatory is prerequisite. Participation in and conducting of licensing evaluations will be part of the role
  • Integrate multiple inputs from regional and functional Global Regulatory Team (GRT) members to create and execute a coherent and unified global regulatory strategy for one or more project(s) (including technology platforms, diagnostics, and others)
  • Refine regulatory strategy as new data become available and re-assess as necessary
  • Lead, facilitate, and coordinate GRT or regulatory subteam meetings
  • Represent Regulatory viewpoint and expertise on the Compound Development Team (CDT), including regulatory risk/benefit evaluations associated with proposed strategies
  • Deliver and execute regulatory strategy for projects for US, EU, and global as necessary
  • Provide input into a strategy for pricing and reimbursement
  • Accountable for regulatory recommendations.
  • Develop and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the projects
  • Confirm strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-RA strategy, commercial strategy, intended use, and target device label
  • In collaboration with Regional and/or local Regulatory Leader, as applicable:
    • Determine timing and strategy for HA meetings
    • Prepare company staff for interactions
    • When appropriate lead meetings with Health Authorities (HA)
    • Develop a strategy for providing responses to HA questions (ensure alignment with global strategy)
  • Negotiate regional device labeling with HAs (ensure alignment with global strategy) as appropriate
  • Provide input to and be accountable for the preparation of dossiers for submission to Health Authorities and Notified Bodies (NBs) as necessary.
  • Work with the clinical team to develop clinical trial submission plans (IDE, notifications, CTAs)
  • Work with the GRT to develop a global marketing approval submission plan and timing
  • Review and be accountable for all contents of submissions to HA and NBs
  • Establish Rapid Response Team to develop and get buy-in on global strategy for HA responses as needed
  • Work with GRT and CDT to comply with local regulatory requirements and commitments
  • Conduct licensing evaluations as needed
  • Work with the GRT to provide input for intended use and Device Target Label
  • As a member of the clinical team, provide input on study design, conduct, country selection, and monitoring and identify need for any additional studies
  • Provide feedback to Discovery and other functions that may translate into potential new compounds/diagnostics/ technologies/biomarkers
  • Provide input to commercial Product formulation, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy
  • Provide input into risk/benefit assessment
  • Work with GRT to direct, manage and resolve any “issues” as required with dedicated resources
  • Consult with Regulatory Legal and Healthcare Compliance to address pertinent issues
  • As part of CDT and DAS, review pertinent product/project-related communications, manuscripts and publications

Qualifications

Qualifications
  • Minimum of Bachelor’s degree in a scientific discipline required
  • Advanced degree (MS, Ph.D., MD or Pharm D) strongly preferred
  • 10+ years of pharmaceutical industry or health authority experience and at least 6 years of RA or related experience required
  • Minimum 4 years of experience within a supervisory capacity or managing teams within matrix environment required
  • Wide range of experience in Regulatory Affairs and experience leading interactions with Health Authorities
  • Working knowledge of WW HA laws, regulations, guidance, and global regulation submission routes available for new study drugs, biomarker development, diagnostics, and drug/device combinations is required. Working knowledge of regulatory pathways for technology platforms is an asset.
  • Detailed understanding of competitors in the area and what they are doing in early/late development and knowledge of labeling aspects required
  • A solid understanding of biology and chemistry relevant to the therapeutic area required
  • Experience developing regulatory strategies and an understanding of product development required

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location

Switzerland-Allschwil--

Organization

Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)

Job Function

Regulatory Affairs

Requisition ID

2105979472W

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Deadline: 04-05-2024

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