Director of Regulatory
Wauconda, IL US
Job Description
Director of Regulatory
Top 100 companies to work for in the Chicagoland area is looking for an experienced Director of Regulatory. Do you have 10+ years of experience in management and international regulatory affairs? Do you have an understanding and background working with the FDA, USDA and EFSA? If so, this could be a great opportunity for you. The company has a lot of stability and an excellent culture!
Duties:
The Director of Regulatory will be responsible for the full range of regulatory matters related to our products and compliance with industry regulations, both internal and external, including (a) general regulatory monitoring and compliance, (b) regulatory analysis of new product development opportunities, (c) issue-specific advocacy on our own behalf and on behalf of the trade groups to which we belong (d) close coordination of product regulatory affairs with our mining and manufacturing operations, and (e) developing new policies and procedures on product regulatory matters on a global basis.
- Ensuring our products’ exhibit ongoing compliance with regulatory requirements in all relevant jurisdictions, 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, filing 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 Food and Feed regulations, FDA and AAFCO Feed regulations, state feed licensing and tonnage free 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 and inquiries
- 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 (sorptive.org), the American Feed Industry Association (www.afia.org) and the Industrial Minerals Association-Europe/European Bentonite Producers Association (www.ima-eu.org)
- Building and maintaining relationships with regulatory authorities and other regulatory body leaders 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.
**If you’d like to hear more about this opportunity and others we are currently working on, please contact Alicia Mytnik at amytnik@cps4jobs.com.
JO: 31.24AM
#LI-AM2
Job Requirements
Technical Qualifications:
- Bachelor or Master of Science degree in Chemistry, Physics, Geology or other physical science from an accredited U.S. university; a Ph.D. degree in any of these disciplines is very desirable; strong undergraduate and graduate school credentials
- 10+ years of experience managing teams in international Regulatory Affairs and advising manufacturers on a broad range of product regulatory affairs, and securing regulatory manufacturers on a broad range of product regulatory affairs, and securing regulatory approvals 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
- Proficiency in the entire Microsoft Office Suite of applications, including Outlook, Word, Excel and PowerPoint
- Willingness to travel approximately 25% of working time, domestically and internationally
**If you’d like to hear more about this opportunity and others we are currently working on, please contact Alicia Mytnik at amytnik@cps4jobs.com.
JO: 31.24AM
#LI-AM2