Tubing)

TekniPlex

1d•Hybrid

About The Position

Global Manager, Regulatory Compliance IPS (Integrated Performance Solutions – Sealing/Lidding/Tubing). 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 Consumer Products Division; attending various seminars and maintaining a view on the regulatory landscape. She/he will partner with Procurement, Quality & others for internal 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 US FDA, equivalent international bodies, and other key US state and Federal requirements. In addition, this role will issue various customer statements on request. This role reports to the Global Regulatory Director – Consumer Products.

Requirements

Education: Bachelor’s Degree in an applicable area such as regulatory, quality, engineering or a technical discipline Experience:
Five (5) or more years of overall relevant experience with three (3) or more years in a regulatory capacity in the food, pharmaceutical or similar industry
Detail oriented, organized and able to manage multiple tasks and projects
Knowledge and experience with applicable regulations (FDA statements, EU 10/2011, 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 the Global Innovation Center (GIC) in Holland, OH USA or Erembodegem Belgium.

Responsibilities

Manage the maintenance of the Consumer Products Rapid Regulatory Response System (RRRS), ensuring raw materials used on the CPD 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
Provide support to Quality and Procurement during SQF Audits; maintain regulatory documentation on an annual basis for multiple plant locations.
Provide timely response to varied customer requests submitted by Quality, Customer Service, Sales, or Others, including FDA statements, EU 10/2011, CONEG, RoHS, TSE/BSE/Animal Origin, Allergens, REACH (SVHC), California Proposition 65, BHT, Bisphenols, Phthalates, PFAS/PFOA/PFOS, Conflict Minerals, MOSH/MOAH, Nitrocellulose/Nitrosamines, others.
Responsible for providing input and technical expertise to internal Regulatory, R&D and Procurement.
Support the ENHESA or any other specialized software activities for the Consumer Products Division.
Actively support the Global Regulatory Director in customer requests, both internal and external.
Work cross functionally with wider business team to ensure all company business objectives are met/exceeded
Coordinates 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.