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Title:  Regulatory Science Nonclinical Director

Job ID:  72208
Country:  Switzerland
City:  Geneve
Professional area:  Scientific Regulatory Affairs
Contract type:  Permanent
Professional level:  Experienced
Location: 

Geneve, GE, CH, 1202

 

We’re JTI, Japan Tobacco International and we believe in freedom. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our consumers to choose from. It’s how we’ve grown to be present in 130 countries.

But our business isn’t just business. Our business is our people. Their talent. Their potential. We believe when they’re free to be themselves, grow, travel and develop, amazing things can happen for our business

That’s why our employees, from around the world, choose to be a part of JTI. It is why 87% of employees feel happy working at JTI. And why we’ve been awarded Global Top Employer status, eight years running

So when you’re ready to choose a career you’ll love, in a company you’ll love, feel free to #JoinTheIdea. 

Learn more: jti.com

 

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.

 

 


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