Global Regulatory Manager IPS-Rubber & Elastomers (Giaggiano, Italy or Schaumburg, IL.)

*This role is hybrid based out of Giaggiano, Italy or Schaumburg, IL*

Global Manager, Regulatory Compliance IPS (Integrated Performance Solutions – Rubber & Elastomers) will be responsible for the completion of customer requests and compliance assurance of all our raw materials and ingredients related to Rubber and Elastomer products and formulations. This role will focus on insuring materials used within the division comply with the TekniPlex regulatory compliance standards; engaging and coordinating with key stakeholders across multiple departments to verify the active material lists; providing regulatory guidance concerning new raw materials as part of new product development (NPD) activities; attending NPD meetings for the IPS - Consumer Products Division; attending various seminars and maintaining a view on the regulatory landscape.

She/he will partner with Procurement, Quality & others for SQF or any other Audits, ensuring current supplier regulatory statements are on-file, compliant and accessible and provide direct support on regulatory matters for the R&D Teams within the Consumer Products Division. This role will provide expertise and guidance in interpreting government regulations, customer requirements, agency guidelines, and internal policies to assure compliance with global standards. Additionally, they will serve as a key representative in the regulatory department for both internal and external functions by insuring compliance with current and future regulations set forth by the USA, EU or any other related agencies and international bodies where we have facilities and/or customers. In addition, this role will issue various customer statements on request. This role reports to the Global Regulatory Director – Consumer Products.

DUTIES AND RESPONSIBILITIES

• Manage the maintenance of the Consumer Products Rapid Regulatory Response System (RRRS), ensuring raw materials used on the different Rubber & Elastomers IPS plant locations are captured, that the regulatory information is current, and provide support to various teams regarding raw materials that are found to have compliance concerns.
• Issue Drug Master File (DMF) Letters of Authorization (LOAs); amend DMFs; and complete FDA annual reports for DMFs and/or any other reports for related Agencies.
• Provide support to Quality and Procurement during SQF or equivalent Audits; maintain regulatory documentation on an annual basis for multiple plant locations.
• Accountable for providing expert-level regulatory support for rubber product compliance, serving as a key partner to global customer and internal teams. This role navigates complex international food contact frameworks (FDA, EU, Asia-Pacific) and conducts deep-dive compliance evaluation for products used at the highly regulated applications: Food contact, Pharma, Medical, Automotive. Example of the regulations and substances of concerns includes REACH, RoHS, Prop 65, Nitrosamines, PFAS, and Mineral Oil Hydrocarbons (MOSH/MOAH).
  Responsible for providing input and technical expertise to internal Regulatory, R&D and Procurement.
  • Support preparing information for in-house information tools or any other specialized software activities for the Consumer Products Division.
  • Actively support the Global Regulatory Director-Consumer Products in customer requests, both internal and external.
  • Work cross functionally with wider business team to ensure all company business objectives are met/exceeded
  • Coordinate with functional teams to implement effective collaboration and knowledge management measures.
  • Participate on various NPD teams to ensure they have appropriate regulatory information for all key development programs.
  • Actively participate in global regulatory community efforts. Evaluate best practices learned from internal or external sources.
  • Participate in information sharing activities as important regulatory concerns arise; generate slide decks and present regulatory information to internal and external customers.

QUALIFICATIONS

Education:

• Bachelor’s Degree in an applicable area such as regulatory, quality, engineering or a technical discipline Experience:
• 5+ years of overall experience on regulatory affairs and product stewardship.
• Deep familiarity with the regulatory landscapes of the chemical and converting sectors.
• Detail oriented, organized and able to manage multiple tasks and projects
• Knowledge and experience with applicable regulations on Rubber components and products (FDA statements, EU Rubber Food Contact Regulations, CONEG, RoHS, TSE/BSE/Animal Origin, Allergens, REACH (SVHC), California Proposition 65, BHT, Bisphenols, Phthalates, PFAS/PFOA/PFOS, Conflict Minerals, MOSH/MOAH, Nitrocellulose/Nitrosamines)
• Has held customer-facing roles within the Regulatory function
• Demonstrated success supporting compliance audits
• Ability to communicate at all levels of the organization, and other third parties.
• Ability to establish credibility, trust and strong working relationships both inside and outside the company. Skill: Excellent interpersonal communication, verbally and in writing, with a diverse range of people; analyzing and independently solving a variety of difficult situations and problems.
• Ability to travel (domestically and globally) up to 25% is required
• This is a hybrid role - remote and local presence close to one of our plants, ideally in the Milan, Italy area close to our Giaggiano Facility, or in the United States near Schaumburg, IL.
• Fluent in English is a must, in addition to Italian.

 US salary range in Schaumburg, IL: $110,00 to $138,000

In addition to a competitive salary, we offer a full complement of valuable Health, Wellness, and Welfare benefits which include:

• Medical, Dental, and Vision
• Life and Disability
• 401(k) and Match
• Wellness Program including EAP
• Pay for Performance philosophy