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Regulatory Science Product Characterization & Analytical Chemistry Manager

What this position is about - Purpose:

In this role you will report to the VP of Regulatory Science and will work closely with the Regulatory Science Nonclinical Director and Manager to support the delivery of product characterization assessments that will be conducted as part of JTI's RRP Regulatory Science Strategy. You will provide scientific and technical input whilst managing the progression and delivery of all externally-conducted studies. This role includes ensuring that all external activities adhere to the scope, testing approach and protocol templates as defined by the Regulatory Science Nonclinical Director. Last but not least, you will also manage the analysis and compilation of product characterization data to be included in regulatory submissions.

What will you do - Responsibilities:

• Work with the Nonclinical Director and Manager to steer nonclinical initiatives related to product characterization by:
  
  • Maintaining close links with contract research organizations, managing contract execution and protocol adherence across the portfolio of Regulatory Science 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 issues (e.g. guideline and standard operating procedure compliance)
  • Managing the integration of product characterization best practices across all Regulatory Science nonclinical initiatives
  • Collation, review and preparation of the pertinent sections to be included in the product characterization portion of regulatory submissions and supporting general engagement activities

• Support and inform annual Regulatory Science planning process:
  
  • Collate information that informs the development of Regulatory Science nonclinical operations activities (internal and external meetings, investigator meetings, discussions with contract research organizations/vendors/third parties, budget)
  • Contribute to the assessment and internal reporting of product characterization and regulatory industry trends
  • Contribute to the assessment of the competitive landscape and regulatory environment and future Regulatory Science research proposals

• Support the Regulatory Science Nonclinical Director and Manager in providing awareness to internal business functions on the requirements and approach of the RRP Strategy as follows:
  
  • Communicating Regulatory Science strategic priorities and deprioritized deliverables
  • Stepping in when the responsibility assignment matrix between functions is not 100% clear, providing the most efficient solution(s)
  • Contributing to business meeting updates
  • Communicating Program and regulatory priorities to JTI's cross-functional teams
  • Managing the collation and preparation of materials to be utilized for publication, internal and external presentations (oral and poster)

• Support the Regulatory Science Nonclinical Director and Manager during interactions with other JTI functions Initiatives and programs by:
  
  • Collating and sharing pertinent Regulatory Science information related to product characterization 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 analytical chemistry or other appropriate chemistry disipline. Relevant certification is a plus
• 3+ years working in a multinational organization in a highly regulated industry (Tobacco, Pharma, medical devices) with experience conducting and/or managing product characterization studies is a must. Practical knowledge of diverse aspects of product characterization including assessment of extractables, leachables and stability, as well as thermal profiling is preferable. Expertise in quantitative (full and semi) methods and analytical technologies such as GC-MS, LC-MS and ICP-MS is desirable. Experience with the US FDA (or other) regulatory environment and regulatory submissions is beneficial
• Excellent English communication skills (both written and verbal)
• Excellent interpersonal and business relationships skills, multi-cultural sensitivity
• 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

What are the next steps – Recruitment process:

Thank you very much for your interest in the role. You are welcome to apply.