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Title:  SRA Scientific Regulatory Affairs Manager

Job ID:  21795
Country:  USA
City:  Teaneck
Professional area:  Scientific Regulatory Affairs
Contract type:  Permanent
Professional level:  Experienced

JTI (Japan Tobacco International) is a leading global tobacco company distributing our products in 130 countries worldwide. One of the fastest growing international industry players we own some of the world’s best known brands, including Winston, the number two global cigarette brand, and Camel, outside of the US.

 

Within the US, JTI has grown to into a total tobacco company with three businesses: JTI USA, marketing and selling key cigarette brands Wave, Wings, Export ‘A’ and the global brand LD; PrimeTime International Distributing, Inc. (PTID), an industry leader in filtered cigars and pipe tobacco; and Logic Technology Development (Logic), a category leader in vapor products.

 

We are a member of the Japan Tobacco Group of Companies. For more information visit www.jti.com

Position Purpose:

Our team is seeking a Scientific Regulatory Affairs (SRA) Manager to join our team. The SRA Manager will support the Scientific & Regulatory Affairs (SRA) Regional Director in leading the management of US SRA projects and challenges. The incumbent provides direct SRA support to the US market and Americas region as applicable, in order to ensure JTI's product portfolio competitiveness, compliance, and sustainable business continuity for conventional products. 

 

The SRA Manager will stay on top through regular monitoring, assessment & communication of FDA’s CTP (Centre for Tobacco Products) tobacco legislation, product regulatory developments, Rules & Guidance’s etc., affecting compliance, pre-market applications, business opportunities and priorities in the US market as well as scientific know how and projects progress within SRA.

This position serves as a liaison support between the HQ SRA (scientific, advocacy, assessments, PMO & reporting teams) and the Regional / Market Business Management (e.g. M&S, R&D, GSC, CA, Legal, BD, …) – the SRA Regions “ambassadorship” role within SRA.

The incumbent takes proactive role on product-related challenges and supports facilitation of the development of SRA state of the art scientific solutions to guide business decisions and strategies.

 

This position is based in our Teaneck, NJ office.

 

Responsibilities:

Regulatory Environment

  • Regular monitoring, interpretation and communication to relevant stakeholders (both in SRA HQ and in other HQ/regional/market functions) of all US tobacco product regulatory developments (for both markets and factories)
  • Review & analyze CTP Guidance documents, SE approvals and evolving pre-market approval requirements in support of US business priorities and market growth objective.
  • Provide advice on business impact and optimal solutions identification.
  • Develop new processes and procedures to ensure business practices for US portfolio complies with evolving regulation.

 

Qualifications & Experience:

  • University degree in chemistry, biochemistry, toxicology or related sciences preferred or Business Management / Economics; Post-graduate degree (Ph.D. or MBA) preferred
  • Minimum 5 years in a managerial position specifically in the tobacco sector, related government agency, NGO or another multinational company from highly regulated industry
  • Sound knowledge and thorough understanding of US FDA and tobacco regulations
  • Strong scientific background with knowledge & experience in regulatory affairs
  • Experienced in:
    • developing regulatory strategies, managing regulatory submissions with the ability to successfully manage projects to deadlines
    • preparing regulatory pre-market approval / Substantial Equivalent submissions to CTP utilizing available scientific data & literature, knowledge and understanding of cigarette design, toxicology of tobacco, tobacco smoke and ingredients
    • utilizing strong technical writing skills to develop responses to Advice Notices / responses to regulators including scientific evidence supporting findings in alignment with corporate positions
    • cross-functional, multi-disciplinary, deadline driven projects management
    • analyzing regulation’s business impact and addressing scientific regulatory issues
    • communicating and negotiating with regulatory authorities and stakeholders
    • product development, material assessment, testing methodologies, quality assurance & control, performance measurements and reporting

       

Functional Skills:

Regulatory, Scientific, Tobacco

  • Very strong knowledge and understanding of tobacco product regulations, compliance as well as regulatory and enforcement organizations processes and functioning
  • Thorough understanding of US tobacco product regulations, FDAs Tobacco Control Act (TCA), CTP pathway to market options, pre-market approval requirements, associated Guidance requirements, etc.
  • Strong business acumen combined with solid scientific knowledge - connecting regulatory and product compliance / scientific issues with business plans and objectives
  • Broad knowledge in the development, design and manufacture of tobacco products; the toxicology of tobacco, tobacco smoke, and ingredients; tobacco product testing methodologies, reporting & submissions; quality control; sensory and behavioral aspects of tobacco products
  • Profound understanding of tobacco industry, product trends/initiatives, competitors’ strategies, actions and positions

General

  • Strong project management skills in managing cross-functional, multi-disciplinary projects - capable of leading a multitude of projects at the same time and to work under high business and time pressure
  • Excellent inter-personal and networking skills, strong verbal and written communication, very good multi-cultural sensitivity, good negotiation skills    
  • Good analytical skills - high attention to detail, ability to identify root of issues
  • Eager to constantly enhance scientific, product and regulatory knowledge

 

Benefits:
Enjoy a competitive salary commensurate with the experience and responsibility requirements.
Excellent employee environment with a competitive benefits package including:

  • Bonus 
  • Annual Merit Increase 
  • Healthcare 
  • Dental 
  • Paid Time Off 
  • 401k Plan + Company Contributions 
  • Life Insurance 
  • Disability
  • Tuition Assistance

 


Nearest Major Market: New York City

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