J&J Family of Companies Global Regulatory Lead Vaccines Director in Pierre, South Dakota
Regulatory Strategy, Health Authorities Interactions, Regulatory Submissions
Integrate multiple inputs from regional and functional GRT (global regulatory team) members to create and execute a coherent and unified global regulatory strategy for one or more product (s)
Refine regulatory strategy as new data become available and re-assess as necessary
Lead, facilitate, and coordinate GRT meetings
Represent Regulatory viewpoint and expertise on the CDT (clinical development team), governance meetings, 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.)
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, assure efficient interactions with Health Authorities (HA)
Provide input to and be accountable for the preparation of dossiers for submission to HA (NDA / MAA / IND/CTA)
Work with the clinical team to develop clinical trial submission plans
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
Regulatory Input into Other Functions
Conduct licensing evaluations (as needed)
Work with the GRT to provide input for Target Label
Provide feedback to Discovery and other functions that may translate into potential new compounds and uses
Provide input to commercial Drug Product formulation, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy
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, review pertinent product/project-related communications, manuscripts and publications
Required Competencies & Knowledge:
• 5-10 years experience in regulatory (one or multiple disciplines; CMC, clinical, labelling, or appropriate experience )
• Understanding of global regulatory procedures available to study new drugs. Broad knowledge covering obtaining licenses in different geographies is preferable.
• Experience in the development of vaccines, scientific degree: medicine, biologic, infectious diseases, immunology, epidemiology, statistics, technical or non clinical
• Excellent English communication skills (verbal & written)
• Team Leadership: The ability to take a role as leader of a team or other group.
• Communication: The ability and intent to effectively explain, describe, or convey information verbally or in writing to individuals and to a wide variety of large and small groups.
• Results and Performance Driven/Initiative: Assumes personal ownership and accountability for business results and solutions; The ability to identify a problem, obstacle or opportunity and take action to address current or future problems or opportunities.
• Organization and Talent Development: Demonstrated ability to foster the long-term learning or development of others.
• Impact and Influence: Able to persuade, convince, or influence others, in order to gain commitment with an idea or a course of action he or she wants others to adopt.
• Organization Awareness: The ability to understand and learn the power relationships in one’s own organization and in other organizations.
• Self Awareness and Adaptability: The ability to keep one’s emotions under control and act professionally when faced with conflict from others, or when working under conditions of stress; puts interest of enterprise above own; keeps the focus of driving customer value and delivering results under stressful situations; the ability to adapt to, and work effectively within a variety of situations, and with various individuals or groups.
• Strategic and Conceptual Thinking: Driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; motivated to leave things better than they were; a change agent. The ability to identify patterns or connections between situations that are not obviously related, and to identify key or underlying issues in complex situations; includes using creative, conceptual or inductive reasoning.
Mobility: this position will require travelling to J&J Vaccines site in Leiden (The Netherlands) (frequency to be determined)
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Europe/Middle East/Africa, North America-United States, Europe/Middle East/Africa-Switzerland-Berne-Bern, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Pharmaceutica N.V. (7555)
J&J Family of Companies
- J&J Family of Companies Jobs