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Regulatory Science Nonclinical Director
What this position is about - Purpose :
Reporting to the VP of Regulatory Science and under their leadership, the incumbent is accountable for providing operational and strategic guidance for all nonclinical toxicological assessments that will be conducted as part of JTI's RRP Regulatory Science Strategy.
The jobholder will lead the execution of all externally conducted nonclinical toxicological assessments with accountability for the overarching regulatory scope, testing approach, and development of associated protocol templates.
The incumbent is accountable for monitoring and cascading best practices for the testing of JTI's RRPs across all Regulatory Science nonclinical initiatives.
The individual will review and sign-off the nonclinical sections of associated regulatory submissions.
What will you do - Responsibilities :
Working with the Regulatory Science VP and other team members to execute nonclinical Regulatory Science initiatives :
Overseeing contracting, protocol development and execution of nonclinical studies conducted at CROs. Includes but is not limited to HPHC analyses, leachables and extractables, microbiology and in vitro and in vivo toxicology studies
Accountable for evaluating and mitigating issues relevant to nonclinical studies, including the interpretation of results, writing and issuance of final reports, timeline changes, and data integrity and / or quality issues (such as GLP and SOP compliance).
Primary representative for assigned nonclinical study teams and also represent Regulatory Science cross-functionally
Monitoring and cascades RRP testing best practices across all Regulatory Science nonclinical initiatives
Accountable for the sign-off on nonclinical sections of associated regulatory submission documentation
Accountable for developing and having total oversight of Regulatory Science internal nonclinical processes, including the development of SOPs and policies, study oversight, and training
Accountable for providing strategic guidance on nonclinical challenges and future developments in the JTI planning processes :
Provides strategic input to Regulatory Science nonclinical operations activities (internal and external meetings, investigator meetings, discussions with CRO / vendors / third parties, budgets)
Anticipates and reports nonclinical and regulatory industry trends
Benchmarks Regulatory Science research activities, leads analysis of the competitive landscape and the regulatory environment, developing future Regulatory Science nonclinical proposal
Influences and provides awareness to other related internal business functions on the requirements and approach of the RRP Strategy :
Confirms Regulatory Science strategic priorities, deprioritizes less important deliverables
Steps in, when ARCI between functions is not 100% clear, providing the most efficient solution(s)
Contributes to OCM and SCM updates
Identifies and communicates pertinent Program and regulatory priorities to JTI's cross-functional teams
Interacting with other JTI functions to respond to regulatory and product compliance challenges :
Key Regulatory Science contact, providing their insights and expertise to cross-functional project teams
Contributes to formal responses to regulatory inquiries and compliance challenges
Monitors and disseminates nonclinical regulatory developments, advising on their impact to JTI's RRP business
Key participant for Regulatory Science in scientific engagement development activities (e.g., publications, presentations)
Key interface with functional managers and Program leadership for resource requests or prioritization of activities :
Support, motivate and guide the professional development of new Regulatory Science team members
Manage additional initiatives as they arise and upon request
Good balance between attention to details and strategic view
Who are we looking for - Requirements :
Degree (Science) preferably to PhD or professional doctorate (e.g., MD, DVM, PharmD) level; Board certified : DABT or equivalent (ERT) required3+ years’ experience working in a multinational organization in a highly regulated industry (Tobacco, Pharma, medical devices) with experience conducting / managing pre-clinical studies is a must.
6+ years' experience working in a multinational organization in a highly regulated industry (Tobacco, Pharma, medical devices) with experience conducting / managing a broad range of nonclinical studies.
Proven experience of overseeing regulatory nonclinical programs and directly interacting with regulatory agencies is desired.
Proven experience developing and validating nonclinical models or conducting quantitative risk assessments for use in regulatory submissions would be beneficial.
Detailed knowledge of GLP and corresponding current US FDA regulations, and knowledge of other relevant global regulatory requirements is a plus.
Experience with PMTA, MRTP and investigational tobacco products applications and evaluating multiple categories within the reduced-risk product space is highly desirable
Ability to assimilate and communicate scientific information at different levels across the organization.
Thinks and acts strategically, must be able to visualize the bigger picture as well as the detail.
Can influence teams without direct line responsibility and lead them towards a singular business solution for common regulatory issues.
Program management skills leading cross-functional teams, including experience in Agile methodology, is required.
Experience working within regulatory frameworks and managing business-relevant scientific programs is essential.
Excellent team player, willing and able to coach, develop and motivate others.
Excellent inter-personal and business relationships skills, multi-cultural sensitivity, good negotiation skills
What are the next steps Recruitment process :
Thank you very much for your interest in the role. You are welcome to apply.