Global Regulatory Specialist IPS-Rubber & Elastomers (Giaggiano, Italy)

• This role is hybrid based out of Giaggiano, Italy

Imagine:

A Career with Purpose and Possibility Picture this: You are part of a global team of problem-solvers whose innovations in materials science can make life better. Every day, you help turn ideas into impact using science, technology, and creativity to tackle real-world challenges. You're part of a company whose work helps improve patient outcomes in healthcare and protects essential consumer goods that people around the world rely on every day. At TekniPlex, you'll join more than 8,000 colleagues across 12 countries, all united by one purpose: creating safer, smarter solutions that touch daily life. Through our two divisions, TekniPlex Healthcare and TekniPlex Consumer Products, you'll help shape industries that matter: healthcare, pharmaceutical, food & beverage, beauty, and personal care. Here, your ideas count and your work matters. You'll be encouraged to think boldly, collaborate across cultures, and keep growing every step of the way. You will help protect the integrity of essential products, support patient safety and comfort, and contribute to innovations that make everyday life better, all while building a career that makes an impact. Because at TekniPlex, you don't just deliver products

• you help shape what's next. Global Regulatory Specialist
• IPS Rubber & Elastomers Role Overview The Global Regulatory Specialist
• IPS (Integrated Performance Solutions
• Rubber & Elastomers) is responsible for ensuring regulatory compliance of raw materials and product formulations across the division.

This role requires a strong understanding of global regulatory frameworks and the ability to independently assess compliance risks, support product development, and respond to customer and audit requirements. The Specialist will serve as a key partner to R D, Quality, Procurement, and Commercial teams, providing regulatory guidance and ensuring alignment with applicable regulations across the U.S., EU, and other relevant markets. Key Responsibilities Support and maintain regulatory compliance for raw materials and formulations across IPS Rubber & Elastomers products Support Manager in managing and ensurring accuracy of regulatory systems (e.g., RRRS), including material tracking and compliance status Evaluate regulatory requirements and assess product compliance across multiple frameworks (e.g., FDA, REACH, RoHS, Prop 65) Provide regulatory guidance to R D and NPD teams, including review and approval of new raw materials and formulations Lead responses to customer regulatory inquiries, including preparation of compliance statements and supporting documentation Prepare and Drug Master File (DMF) documentation, including LOAs, amendments, and annual reporting Partner with Quality and Procurement to ensure supplier regulatory documentation is complete, current, and audit-ready Support and participate in internal and external audits (e.g., SQF), serving as a regulatory subject matter resource Monitor and interpret changes in the regulatory landscape and communicate potential impacts to the business Collaborate cross-functionally to drive compliance, resolve issues, and support business objectives Contribute to continuous improvement of regulatory processes, tools, and data management Prepare and deliver presentations or summaries on regulatory topics to internal stakeholders Scope & Complexity Responsible for regulatory compliance across multiple product lines within Rubber & Elastomers Supports a global footprint (U.S., Italy, Belgium) across a limited number of manufacturing sites Handles moderate to high product and regulatory complexity, including chemical and food-contact applications Operates with a high level of independence in day-to-day responsibilities, escalating only complex or high-risk issues

Qualifications & Experience:

Bachelor's Degree in Regulatory, Chemistry, Engineering, or related technical field 5-8+ years of experience in regulatory affairs, product stewardship, or compliance within a chemical or manufacturing environment Strong working knowledge of global regulatory frameworks (FDA, EU Food Contact, REACH, RoHS, Prop 65, etc.) Experience supporting audits, customer interactions, and regulatory documentation

Skills:

Strong technical and regulatory interpretation skills Ability to independently assess compliance and provide guidance to cross-functional teams Highly organized with strong attention to detail and documentation accuracy Effective communication skills with both technical and non-technical stakeholders Ability to manage multiple priorities in a fast-paced environment