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Title:  Scientific & Regulatory Affairs Manager

Job ID:  71227
Country:  USA
City:  Miami
Professional area:  Scientific Regulatory Affairs
Contract type:  Permanent
Professional level:  Experienced
Location: 

Miami, FL, US, 33131

 

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

 

Position Purpose

The incumbent provides direct SRA support to the Markets as well as Regional and HQ Functions to ensure JTI's product portfolio competitiveness, compliance, and sustainable business continuity for conventional and reduced risk products. He / she stays on top of product regulatory developments and business priorities as well as scientific know how and projects progress within SRA.

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

The incumbent’s ambition is to provide ongoing support for Market/Regional Management when it comes to product regulatory and product scientific issues, while actively participating in SRA cross-regional and global projects following the new ways of working principles and mind-set.

The incumbent takes a proactive role in product compliance / regulatory challenges and facilitates the development of SRA state of the art scientific solutions to guide business decisions and strategies.

 

Location - Miami, FL Candidates should reside in the local market or open to relocation

 

Education          

  • University degree in chemistry, biochemistry, toxicology or related sciences preferred
  • Business Management / Economics as a secondary option
  • Post-graduate degree (Ph.D. or MBA) being a bonus

 

Work Experience            

  • Minimum 5 years in a managerial JTI position or in another multinational company from highly regulated industry, preferably tobacco or pharmaceutical; secondary food or cosmetics
  • Good knowledge and understanding of global regulatory trends and regulatory bodies for tobacco / consumer products
  • Proven track record in engaging with regulatory bodies
  • Basic knowledge of consumer expectations and consumption patterns & trends
  • Experienced in:
    • working in close cooperation with business functions
    • cross-functional, multi-disciplinary projects management
    • working in matrix organizations
    • analyzing regulation’s business impact and addressing scientific regulatory issues
    • product development, material assessment, testing, quality assurance & control, performance measurements and reporting
    • 3rd parties management (e.g.,laboratories, science institutes)
    • Agile ways of working
    • budget control 

 

Language & Computer Skills

  • Fluent in English, other regional languages (e.g., Portuguese, Spanish) would be a bonus
  • Proficiency in Microsoft Office and SAP environments

 

Functional Skills              

General

  • Strong business acumen combined with solid scientific knowledge - connecting regulatory and product compliance / scientific issues with business plans and objectives
  • Excellent inter-personal and networking skills, strong verbal and written communication, very good multi-cultural sensitivity, good negotiation skills  
  • Cross-functional, multi-disciplinary projects management - capable of leading multitude of projects at the same time and to work under high business and time pressure
  • Capable of seeing the big picture and developing solutions / strategic framework in cooperation with other functions
  • Good analytical skills - high attention to detail, ability to identify root of issues
  • Situational leadership and management competencies
  • Results driven, proactive attitude

 

Regulatory, Scientific & JTI/ Tobacco

  • Very good knowledge and understanding of product regulations, compliance as well as regulatory and enforcement organizations processes and functioning
  • Solid scientific expertise, basic knowledge of e.g.: ingredients, flavors, non-tobacco materials, toxicology, product development and design, growing and production processes, quality assurance and control processes, equipment, sampling, testing methodologies, reporting & submissions
  • Good knowledge and understanding of JTI’s culture, structure, relevant systems, processes and procedures
  • Understanding of tobacco industry, product trends/initiatives, competitors’ strategies, actions and positions
  • Eager to constantly enhance scientific, product and regulatory knowledge

 

Main Areas of Responsibility

  1. Regulatory Environment

Monitoring, interpretation, and communication to relevant stakeholders (both in SRA HQ and in other HQ/regional/market functions) of all product regulatory requirements development (for both markets and factories). Providing advice on business impact. Leading optimal solutions identification.

 

  1. Representation of JTI in product regulatory developments

Promoting JTI interests via proactive engagement in product regulatory meetings and dialogue with authorities, national & regional standardization bodies and relevant industry / trade associations with the ultimate goal of developing proportionate and fact-based product regulations and preserving JTI’s flexibility to manufacture competitive products. Leading scientific engagement in region/markets to advocate for JTI product related positions.

 

  1. Ensuring compliance on market level

Expert resource in the case of regulatory product compliance issues and challenges, related to, e.g.:

1) Sampling, testing, monitoring & reporting programs,

2) Contracts and processes with laboratories,

3) Pre-market notifications & reporting for new and changed products,

4) Post-submission queries clarification, and responses,

5) Facilitation of SRA feedback to health-related consumer complaints and inquires,

6) Key material approval processes and related documentation,

7) Representing SRA during authorities’ audits

8) Follow up with markets, region and HQ functions to ensure agreed actions on product compliance related matters are effectively implemented.

 

  1. Mergers & Acquisitions (M&As)

Representing SRA in integration committees for M&As. Managing and facilitating, e.g.: 1) within due diligence: verification of product regulatory requirements and to-be-acquired products compliance, 2) product & suppliers data sourcing, 3) identification of product assessments necessities & sampling/testing/reporting obligations, 4) management of timelines and deadlines, 5) post acquisition implementation of agreed actions

 

  1. Cooperation within the Region

Developing and maintaining network, processes, and effective cross-functional communication (e.g., with M&S, R&D, BD, CA&C, Legal, GSC …) for management of challenges and ensuring of product compliance.

Participation in relevant market and regional meetings, providing scientific expertise and knowledge and delivering regular SRA updates on product regulations, scientific developments, and projects progress.

Providing strategic guidance on scientific & regulatory issues/future developments into regional planning processes (e.g., ASP) regarding, e.g.: new product developments & launches, new markets entries and new businesses acquisitions.

Supporting the implementation of pragmatic business solutions and contingencies.

Giving SRA trainings/workshops/updates/inductions (know - how dissemination) to other functions.

 

  1. Collaboration within SRA

Ensuring efficient network, processes and effective cross-teams’ communication (e.g., with scientific, advocacy, assessments & reporting teams) for management of challenges and ensuring of product compliance.

  • Participation in relevant SRA meetings and providing timely heads-up to HQ SRA on key product regulatory developments, regional business strategies & initiatives, projects progress and business priorities.
  • Informing SRA assessments and reporting team’s priorities.
  • Internal alignment with other SRA teams on optimal approaches, solutions and timings.
  • Pro-active exchange of information regarding product regulatory developments, competitive strategies and JTI business initiatives with other SRA Regions colleagues, for synergies and expertise growth.
  • Identification of efficiencies & coming up with improvements when it comes to processes, procedures and communication channels. 
  • Identification of projects suitable for short-term job rotations / exchange programs.

 

  1. Leading and managing
  • Active, participating member of the SRA Regions & Agile Operations team including;
  • proactively taking on agile roles and educating, motivating and coaching colleagues for their personal and overall team’s competencies and skills growth
  • team agile mind set building including regular feedback giving and receiving / issues management and resolution
  • enhancement of managerial, scientific and technical knowledge & skills of team members
  • identifying efficiencies and coming up with improvements when it comes to Agile ways of working, processes, procedures, communication and collaboration
  • actively sharing learnings and best practices within the department and cross-functionally in order to increase team’s effectiveness, quality and timelines of services
  • working closely with JT teammates to facilitate further the One SRA Team mind set and acting

 

  1. Others

Accountable for:

- self-development - keeping abreast of product related scientific news; improving technical,

  scientific and agile/managerial knowledge & skills

- supporting direct manager (Principal Director, SRA Regions & Agile Operations) and SRA management team on global projects, challenges and ad hoc requests

- management of additional tasks (e.g., becoming SRA SPOC on a given project) 

- regional compliance budget if relevant

 

 

 Benefits 

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

  • Annual Performance based Bonus 
  • Annual Merit Increase  
  • Healthcare  
  • Dental + Vision
  • Voluntary benefits
  • Paid Time Off  
  • Paid family leave benefit
  • 401k Plan + Company Contributions  
  • Life Insurance  
  • Disability 
  • Tuition Assistance

 

 

 

“JTI offers equal employment opportunity and will not discriminate on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service, or other non-merit based factors.        

              


Nearest Major Market: Miami

Job Segment: Regulatory Affairs, Compliance, M&A, Pharmaceutical, Chemistry, Legal, Management, Science

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