Title:  Regulatory Science Product Characterization Manager - Danville, VA

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Department: Regulatory Science

Location: Danville, VA

Reporting to: Regulatory Science Vice President

Regulatory Science Product Characterization Manager

Reporting to the VP of Regulatory Science and under their leadership, the incumbent will work closely with the Regulatory Science Nonclinical Director and Manager to support the delivery of product characterization and stability assessments that will be conducted as part of JTI's RRP Regulatory Science Strategy. The job holder will provide scientific and technical input whilst managing the progression and delivery of assigned externally conducted studies. The job holder will ensure that all external activities adhere to the scope, testing approach and protocol templates as defined by the Regulatory Science Nonclinical Director. The individual will also be responsible for performing quality control reviews (QC) of all data and reports provided by external vendors.

Position:

As the Regulatory Science Product Characterization Manager you will:

Works with the Nonclinical Director and Manager to steer nonclinical initiatives by: 

• Maintaining close links with assigned contract research organizations, managing contract execution and protocol adherence across the portfolio of Regulatory Science studies conducted externally
• Serve as study monitor, managing data QC, interpretation, writing and issuance of final reports, ensuring data integrity, and resolution of quality issues (e.g. guideline and standard operating procedure compliance)
• Managing the integration of product characterization best practices across all Regulatory Science nonclinical initiatives
• QC and technical review and, as required, preparation of the pertinent sections to be included in the product characterization portion of regulatory submissions and, as needed, supporting general engagement activities

Supports and informs annual Regulatory Science planning process:

• Collates 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)
• Contributes to the assessment and internal reporting of product characterization 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 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).

Supports 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

Requirements:

• Degree (Masters or PhD level preferred, or BS with relevant experience) in biology, toxicology, analytical chemistry or other similar disciplines.
• Relevant certification(s) is/are a plus.
• 3+ years working in a multinational organization in a highly regulated industry (Tobacco, Pharma, medical devices) with experience conducting and/or managing and performing QC product characterization/nonclinical studies, such as aerosol chemistry, in vitro toxicology, leachable & extractables, is a must.
• Practical knowledge of diverse aspects of product characterization including assessment of extractable, leachable and stability, as well as thermal profiling is preferable.
• Working knowledge of quantitative 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 desirable.
• Cross-functional team player who can work independently with minimal supervision.
• Good organization and communication skills, with the ability to analyze, synthesize, utilize, and convey information provided by internal and external stakeholders concisely, clearly, and simply.
• High attention to detail and ability to review large amounts of material efficiently and effectively.
• Excellent interpersonal and business relationship skills, multi-cultural sensitivity.

What We Offer 

In JTI USA, we are proud to be recognized as Top Employer and awarded the Global Equality Standards certificate as we continue our dedication to equal pay and equal opportunities. 

Our culture is what makes JTI USA a fun and exciting environment to work in. We value integrity, trust, empowerment, and freedom - freedom of choice, freedom of thought, freedom of expression, and freedom to be yourself. 

We ask for accountability, ownership, results, and collaboration. 

And we care for our people's well-being - In addition to the salary, you might want to enjoy the following: 

• Annual Performance-based Bonus
• Employee Stock Purchase Plan 
• Personal Development 
• Medical/ Dental & Vision Plan for employees & family members.
• Life insurance
• Matching 401(K)
• Paid Time Off (PTO)
• Paid Family Leave of 20 Weeks
• Short-Term & Long-Term Disability 
• Education/ Tuition Assistance
• Flexible Dress Code
• Hybrid Work Setup 
• Snacks & Drinks
• Office Parties 
• Volunteering Activities 
• Employee Assistance Program - counseling, for employees & family members. 

In addition to other perks & benefits (i.e. fitness/ wellbeing activities, employee discounts, service awards, recognition program, etc.)

Are you ready to join us? Build your success story at JTI. Apply now!

Next Steps:

After applying, if selected, please anticipate the following within 1-3 weeks of the job posting closure: Phone screening with TA > Assessment tests > Interviews > Offer. Each step is eliminatory and may vary by role type.

At JTI, we strive to create a diverse and inclusive work environment. As an equal-opportunity employer, we welcome applicants from all backgrounds. We are committed to providing reasonable adjustments to applicants with special needs. If you require any accommodations, please let the Talent Advisor know during the selection process.