Global Regulatory Strategy Lead Vaccines, Director Key responsibilities
Regulatory Strategy , Regulatory Submissions
- Develop regulatory strategy for one or more products (vaccines) in collaboration with regional and functional GRT (global regulatory team), develop global regulatory strategy plan and risk/mitigation, and execute the strategy
- Refine regulatory strategy as new data become available and re-assess as necessary
- Provide direction on implications for regulatory strategy through participation in other teams (labeling working group, clinical, market access, medical affairs, etc.)
- Represent Regulatory viewpoint and expertise at governmental meetings within the organization (clinical, CMC … ), including regulatory risk/benefit evaluations associated with proposed strategies
- 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
- Develop and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product
- 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
Regulatory Input into Other Functions
QualificationsRequired Competencies & Knowledge:
- Conduct licensing evaluations (due diligences, 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
- 5-10 years experience in regulatory (one or multiple disciplines; procedural , CMC, clinical, labelling, or appropriate experience ). Relevant experience in field of vaccines, good knowledge of clinical development of vaccines.
- Proven experience in global regulatory procedures available to study new drugs/biologics. Broad knowledge covering obtaining licenses in different geographies is preferable.
- Substantial 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.
Europe/Middle East/Africa-Switzerland-Berne-Bern, Europe/Middle East/Africa-Netherlands-South Holland-LeidenOrganization
Janssen Pharmaceutica N.V. (7555)Job Function
Regulatory AffairsRequisition ID