Regulatory Affairs & Compliance Manager

Regulatory Affairs & Compliance Manager

Job Overview

Location
Rotonda West, Florida
Job Type
Full Time Job
Job ID
129458
Date Posted
1 year ago
Recruiter
Charles Karen
Job Views
190

Job Description

The position of EMEA Product Stewardship and Regulatory Affairs will be based in the EU (preferably in Belgium or The Netherlands; however, working remotely will be considered).  
 
The candidate will lead a team, either directly or indirectly, that is 
responsible for Product Stewardship and Regulatory Affairs (PSRA) subject matter supporting Eastman’s businesses within Europe, the Middle East and Africa (EMEA).  This support includes regional-specific regulations such as the EU, UK and Turkey REACH regulations and the EU’s new Chemical Strategy for Sustainability initiative.  In addition, the candidate will lead the PSRA support for one or more Eastman business units globally.   The position reports to the Director of Global Product Stewardship and Regulatory Affairs (PSRA).  The successful candidate will work closely with all staff within PSRA, including other subject matter experts (SMEs) and technical/regulatory staff.  Outside of PSRA, the candidate will regularly engage key internal stakeholders within Eastman’s business units, Technology, Legal and Analytical Services.  The scope of the role includes the support of existing products, and the development and commercialization of new products in the application area.  Finally, the candidate’s engagement with external stakeholders such as customers, regulatory authorities and industry associations will be of utmost importance in this position. 

Task and Responsibilities 

Tasks and responsibilities:
 

  • Along with staff supporting specific Eastman businesses, ensure compliance for those product lines.
  • Be a driver in developing stewardship and regulatory strategies for each business unit(s) under the candidate’s area of responsibilty (i.e., personally lead some of those strategies and coach other PSRA staff to develop the remainder).
  • Business Uni support includes:
  • Acquire in-depth product knowledge of our current and developing portfolio, in order to answer compliance related questions from internal stakeholders, partners, external parties and engaging new and existing customers in critical discussions.  
  • Create proposals to support regulatory clearance for new and existing products in specific applications.
  • When needed, support and defend new clearance dossiers before regulatory authorities.
  • Provide appropriate information to promote the safe use of our products throughout their entire life-cycle to: 
  • Internal Stakeholders - including product stewardship experts, manufacturing, technology, product management and sales and marketing personnel.
    • External Stakeholders – including customers, distributors and industry partners.
    • Evaluate and ensure continued compliance with existing regulatory clearances as technology, raw materials, use patterns and governmental requirements change.
  • Work closely with members of the Eastman Law Department and/or contracted regulatory consulting companies and external service providers.
  • Develop/maintain a sound awareness of global trends in product related regulations.
  • Participate in advocacy and regulatory compliance initiatives.  Represent Eastman in trade associations and organizations (e.g., CEFIC). 

Requirements 

Strong candidates for this position should have many of the following skills or be willing to be trained in these areas:
 

  • Education – B.S. or higher degree in Polymer Science, Chemistry, Engineering, or related-scientific field. An Advanced degree in one of these fields is a plus.
  • Experience – This leadership position requires 7+ years of experience within a regulatory function.  Experience in REACH-regulated fields is required.  Global regulatory knowledge is a plus.
  • Comprehension and demonstrated application of procedures/processes used for the approval of chemicals.
  • Hands-on product stewardship/compliance experience.
  • Ability to work independently and on multiple projects simultaneously.
  • Ability to work effectively in a team and matrix organization together with other regulatory and scientific subject experts, and with business organizations.
  • Be skilled in translating complex scientific topics into comprehensible key messages for different audiences.
  • Ability to engage effectively with authorities, customers, industry groups and other stakeholders.
  • Have strong communication skills, both written and orally.
  • Positive and supportive attitude is a must.
  • Proactive, technically competent, assertive, and ability to successfully perform in high-pressure, globally, and culturally diverse environments.
  • Ability to make decisions with incomplete data.
  • Travel occasionally, primarily within the region; but, other geographies are a possibility.
  • Speak and write fluent English is mandatory for the position.

Job ID: 129458

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