Johnson & Johnson Careers
Global Regulatory Leader
Requisition ID: 1905720443W
Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for an Global Regulatory Leader Pulmonary Hypertension TA. The position will be based at either of the following Actelion sites: US (Cherry Hill, NJ) or Switzerland (Allschwil).
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.
Actelion 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, biomarker based IVDs, devices, etc.), linking them with drug treatments, and also support of biomarker development (early clinical decision-making markers and predictive markers of outcomes). A specific interest and expertise in these areas is required. Participation in and conducting of licensing evaluations will be part of the role.
- Integrate multiple inputs from regional and functional 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
- Provide direction on implications for regulatory strategy through participation in other teams (labeling working group, clinical, etc.)
- Provide input into strategy for pricing and reimbursement
- Accountable for regulatory recommendations for governance processes.
- Develop and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product
- Confirm strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-RA strategy, commercial strategy and Target 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 strategy for providing responses to HA questions (ensure alignment with global strategy)
- Negotiate regional labeling with HAs (ensure alignment with global strategy) as appropriate
- Provide input to and be accountable for the preparation of dossiers for submission to HA (NDA/MAA//IND/CTA and others)
- Work with the clinical team to develop clinical trial submission plans
- Work with the GRT to develop global marketing approval submission plan and timing
- Modify submission plan and align with sourcing, IP and launch strategies
- 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 Target Label
- Co-lead the Labeling Working Group in making strategic decisions, including creation of Labeling strategy
- 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
- Minimum of Bachelor’s degree in a scientific discipline required
- Advanced degree (MS, PhD, 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
- Solid understanding of biology and chemistry relevant to therapeutic area required
- Experience developing regulatory strategies and an understanding of product development required
If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)