Global Regulatory Lead Vaccines Director
Global Regulatory Lead Vaccines Director
Posted on :
24-08-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
24-08-2025
Job Description
Key responsibilities
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 ones own organization and in other organizations.
Self Awareness and Adaptability: The ability to keep ones 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)
Whats 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.
Required Experience:
Exec
Employment Type
Full Time
Department / Functional Area
Key Skills
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