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Title:  Regulatory Science Nonclinical Manager

Job ID:  72205
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 Manager

 

What this position is about - Purpose:

Reporting to the VP of Regulatory Science and under their leadership, the incumbent will work closely with the Regulatory Science Nonclinical Lead to support the delivery of all nonclinical assessments that will be conducted as part of JTI’s Regulatory Science Strategy. The jobholder will provide scientific and technical input whilst managing the progression and delivery of all externally-conducted nonclinical assessments.  The jobholder will ensure that all external activities adhere to the scope, testing approach and protocol templates as defined by the Regulatory Science Nonclinical Lead. The individual will also manage the analysis and compilation of nonclinical information to be included in regulatory submissions

 

What will you do - Responsibilities:

  • Works with the Nonclinical Lead to steer pre-clinical initiatives by: 
    • Managing contract execution and protocol adherence across the  portfolio Regulatory Science nonclinical studies conducted externally
    • Managing the implementation of mitigation plans for study issues relating to timeline changes, data interpretation, writing and issuance of final reports, data integrity and/or quality
    • Managing the integration of nonclinical best practices across all Regulatory Science nonclinical initiatives
    • Collation, review and preparation of the pertinent sections to be included in the nonclinical portion of regulatory submissions and supporting general engagement activities
  • Supports and informs annual Regulatory Science planning process:
    • Collates information that informs the development of Regulatory Science nonclinical operations activities
    • Contributes to the assessment and internal reporting of nonclinical and regulatory industry trends
    • Contributes to the assessment of the competitive landscape and regulatory environment and future Regulatory Science research proposals
  • Supports the Regulatory Science Nonclinical Lead in providing awareness to internal business functions on the requirements and approach of the Risk Related Products Strategy:
    • Responsible for communicating Regulatory Science strategic priorities and deprioritized deliverables
    • Responsible for communicating Program and regulatory priorities to JTI's cross-functional teams
    • Manages the collation and preparation of materials to be utilized for publication, internal and external presentations (oral and poster)
  • Supports the Regulatory Science Nonclinical Lead during interactions with other JTI functions Initiatives and programs by:
    • Collating and sharing pertinent Regulatory Science nonclinical information with cross-functional project teams, including the cascade of nonclinical regulatory developments and their impact on JTI’s RRP business
    • Participating in the development of scientific and technical engagement materials to be utilized

 

Who are we looking for - Requirements:

  • Degree or PhD in toxicology or other appropriate life science.
  • ERT (European Registered Toxicologist), DABT (Diplomate of the American Board of Toxicology) and/or other relevant certification is a plus
  • 3+ years of 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.
  • Proven knowledge of the manufacturing processes of tobacco and nicotine containing products, toxicological risk assessment procedures (with a minimum of three years of practical experience), toxicological test strategies and statistical analysis, is preferred.
  • Knowledge or experience with emerging toxicological and risk assessment technologies such as high throughput in vitro testing, systems and computational toxicology, exposure modeling, alternative exposure systems such as air-liquid interface, etc. are a plus
  • Excellent English communication skills (both written and verbal) are a must.
  • Cross-functional team player who can also work independently with minimal supervision.
  • Good organization and communication skills, with the ability to analyze, synthesize, utilize, and convey information provided from internal and external stakeholders effectively and efficiently.
  • Excellent inter-personal and business relationships skills, multi-cultural sensitivity.

 

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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