Senior Regulatory Specialist

vor 2 Wochen

Hannover, Deutschland Element Solutions Inc Vollzeit

**Business Overview**:
**Job Purpose**:
To integrate into the R & D, Marketing and other business units for new and existing products so as to present the regulatory landscape, to communicate upcoming regulations and changes to existing regulations that affect MacDermid Enthone products, and to author Safety Data Sheets for U.S. products and Asia products. To designate transport classifications for new products, as well as packaging specifications for new packages in the MacDermid Enthone product line.

**Responsibilities**:

- Assign and maintain DOT/IATA/IMDG Shipping information to new and modified products, prepare shipping documents for hazardous materials, maintain central label database, advise external customers on DOT related issues
- Recommend packaging types/specification for UN certified containers when new packaging is to be introduced, as well as investigate packaging incident issues
- Author product SDSs that conform to global requirements
- Provide and maintain the correct labeling information for new and existing products.
- Responsible for DEA, DFARS, and ITAR regulations
- Investigate TSCA status of products and imported raw materials and complete all necessary paperwork to assure compliance
- Prepare and review regulatory submissions for Government and State Agencies
- Assess product compliance with all Dept. of Commerce regulations
- Respond to written and verbal technical requests and customer inquiries related to product compliance certifications such as RoHS, JIG and other regulations
- Coordinate with Export Dept. to classify International Tariff Commodity Codes for product and non-products, as well classify samples for international shipment to and from the U.S

**Requirements & Qualifications**:

- Stay up-to-date with European regulatory requirements, standards, and guidelines related to chemicals, materials, and related industries of ESI
- Manage regulatory compliance projects, including the registration, notification, and submission of regulatory dossiers for product approvals and market access for ESI
- Provide expert regulatory advice and guidance to internal stakeholders, including product development teams, manufacturing sites, and sales and marketing teams via the relevant product commercialization process like MFD, Global Formulation´s or PEP
- Conduct thorough assessments of products and processes to identify potential regulatory risks and develop strategies to mitigate them within the MFD process
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements throughout the product lifecycle, from development to commercialization.
- Monitor changes in regulatory frameworks within the EU team, assess their impact on the company's products and operations, and proactively recommend necessary adjustments for the distinct business unit.
- Interface with regulatory authorities and industry associations to address inquiries, participate in consultations, and represent the company's interests in regulatory discussions.

**Skills**:

- IT literacy is essential; with experience using Word, Excel,
- PowerPoint, Microsoft outlook, SAP; JDE and SDS Authoring software (e.g Intelligent Authoring from Sphera ; ChemGES from Dr Software, WERC´s from UL) and different internal and external data bases
- Experience in EU, Turkey and UK regulations (ie. REACh, GHS/CLP, RoHS, WEEE, PIC, PFAS)
- Safety data sheet and EU label requirements for whole Europe region including UK, Turkey and Swiss
- High level of communication skills.
- The ability to effectively present information both verbally and written to customers or regulatory agencies.
- Fluency in English is required. Proficiency in additional European languages like German, Polish, Czech or Hungarian is a plus

**Competencies**:
Demonstrated ability to work collaboratively in cross-functional teams

**Education**:

- Bachelors Degree in Chemistry or Material Sciences

**Supervisory Responsibilities**:
Guidance on Regulatory Scientist within the EU group

**EEO Statement**:
Element Solutions Inc group of companies are E-Verify Companies and provide reasonable accommodation for qualified individuals with disabilities and disabled veterans in job applicant procedures. Equal Opportunity Employer: Minority/Female/Veteran/Disabled/Gender Identity/Sexual Orientation

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