Senior Director, Regulatory Affairs
2 weeks ago
The Senior Director of Regulatory Affairs will be responsible for the full range of regulatory matters related to our products and compliance with industry regulations, both internal and external,including:general regulatory monitoring and compliance, regulatory analysis of new productdevelopment opportunities, issue-specific advocacy on our own behalf and on behalf of the tradegroups to which we belong close coordination of product regulatory affairs with our mining andmanufacturing operations, and developing new policies and procedures.
Essential Functions:
Ensuring our products’ exhibit ongoing compliance with regulatory requirements in all relevantjurisdictions, including oversight of preparation and updating of Safety Data Sheets
Coordinating with internal and external stakeholders to develop strategies addressing changes in product, operations, testing requirements or regulatory concerns
Developing and documenting processes, systems, and procedures to ensure all necessary licensing, filling and certifications are processed and monitored
Implementing, documenting, and ensuring compliance with all regulatory requirements (for
example, those arising out of the European Union’s REACH legislation, European Union Foodand Feed regulations, FDA and AAFCO Feed regulations, state feed licensing and tonnagereports, domestic and international feed labeling, OSHA Haz Com labeling, CUSMA and otherfree trade agreements, California Proposition 65, Canada’ Chemical Management Plan legislation and the multi-jurisdictional GHS initiative)
Responding to element-specific issues and inquiries (whether from customers, regulatory
authorities or other third parties), as well as general product content and labeling issues andinquiries
Oversight of global product registration process, including obtaining necessary product analyses, and other documentation
A working knowledge of US and International tariff codes
A working knowledge of third-party product certifications such as Organic, Kosher and Halal
A working knowledge of EPA and Canada’s Pest Management Regulatory Agency (PMRA)pesticide and inert product registrations
Oversight over internal and external portals and documentation requests
Analyzing and advising on the regulatory aspects for new product development and other
marketing opportunities
Participating as our senior technical representative in all trade group activities, including but not limited to Sorptive Minerals Institute (www.sorptive.org ), the American Feed IndustryAssociation (www.afia.org ) and the Industrial Minerals Association-Europe/European BentoniteProducers Association (www.ima-eu.org )
Building and maintaining relationships with regulatory authorities and other regulatory bodyleaders on relevant product regulatory issues
Managing, training and mentoring one or more Regulatory team members
Developing and maintaining an all-inclusive library of regulatory documentation, SOP’s,
timelines, regulatory matrix, certifications, etc.
Qualifications:
Bachelor or Master of Science degree in Chemistry, Physics, Geology or other physical sciencefrom an accredited U.S. university; a Ph. D. degree in any of these disciplines is very desirable;strong undergraduate and graduate school credentials
At minimum of ten years’ experience managing teams in International Regulatory Affairs and advising manufacturers on a broad range of product regulatory affairs, and securing regulatoryapprovals from bodies such as the FDA, USDA and EFSA (European Food Safety Authority);prior experience advising industrial minerals manufacturers is very desirable
Related professional accreditations (such as Certified Industrial Hygienist or Diplomate,
American Board of Toxicology) are very desirable
Strong oral and written communication skills; strong organizational and prioritization skills
Bias toward action, with a desire to advocate on scientific and regulatory issues
Proficiency in the entire Microsoft Office suite of applications, including Outlook, Word, Exceland PowerPoint
Willingness to travel approximately 25% of working time, domestically and internationally
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