Regulatory Science Nonclinical Manager

vor 1 Woche

Geneve, Schweiz JTI - Japan Tobacco International Vollzeit

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.

**REGULATORY SCIENCE NONCLINICAL MANAGER**

**What this position is about - Purpose**:
Reporting to the VP of Regulatory Science and under their leadership, Regulatory Science Nonclinical Manager is accountable for providing operational and strategic guidance for all nonclinical toxicological assessments that will be conducted as part of JTI's Regulatory Science Strategy. She / He 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. She / He is accountable for monitoring and cascading best practices for the testing of JTI's Reduced Risks Products 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 Clinical Research Organizations which includes but is not limited to HPHC analyses, leachable and extractables, microbiology and in vitro and in vivo toxicology studies
- Is 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
- Is a primary representative for assigned nonclinical study teams and represent Regulatory Science cross-functionally
- Monitors and cascades Reduced Risk Products testing best practices across all Regulatory Science nonclinical initiatives
- She / He is accountable for the sign-off on nonclinical sections of associated regulatory submission documentation
- She / He is accountable for developing and having total oversight of Regulatory Science internal nonclinical processes, including the development of Standard Operating Procedures 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 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 (Accountability, Responsibility, Consulted, Informed) 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:

- Acts as Key Regulatory Science contact, providing 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 business
- Is a Key participant for Regulatory Science in scientific engagement development activities (e.g. publications, presentations)

**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) required
- 3+ years’ experience working in a multinational organization in a highly regulated industry (Tobacco, Pharma, medical devices) with experience conducting/managing pre-clinical stu

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