Product Stewardship and REACH Expert

Join our HSE Product Stewardship and REACH team in this key expert role, where you will drive regulatory compliance and chemical safety activities across EUROAPI sites. You will act as a subject matter expert on REACH and global chemical regulations, supporting product stewardship and ensuring end-to-end compliance.

Key Responsibilities

Product Stewardship

• Training the product stewardship team, Site REACH Coordinator and HSE Colleagues on Regulatory topics such as REACH, CLP, SDS and PCN

• Expert Review and Classification of hazardous substance and mixtures to ensure compliance according to REACH, Safety data sheet and CLP Regulations

• Provide new Regulatory and chemical compliance information to the product stewardship team and the HSE site colleagues to ensure compliance according to the Regulation.

• Creation and Review of Hazard Classification sheet for Classification and labelling of substances and mixtures.

• Assigning OEB bands and OEL occupational exposure limits according to the internal classification of the pharmaceutical active substance and recommended OEL according to Authorities

• Active expert in classification and notification of substance or mixture for Water Hazard Classification (WGK) Regulation.

• Expert in storage Class Classification according to TRGS-510

• Provide expert knowledge on Regulatory questions on REACH, Safety data sheet, CLP for product stewardship team and HSE Colleagues

• Classification of substance and mixture according to the Dangerous Goods Regulation The product stewardship team manages the Safety data sheet SEDDA database, provides compliant SDS by analyzing the substance test data such as Physio-chemical properties, Toxicology and Environmental toxicology studies to ensure chemical compliance 

• Creation and submission of Poison center notification and CLP inventory Notifications

• Create Global regulatory newsletter to ensure Euroapi Site compliance with chemical regulations

• Responsible for the following tasks:

  • Safety data sheet creation and review

  • Hazard classification sheet

  • Classification and Labelling

  • Regulatory questions

  • Dangerous goods Classification

  • Storage Class Classification

  • Poison Centre Notification 

  • Classification and Labelling inventory Notification

  • Trainings on Product Stewardship Topics

  • Regulatory brief creation

  • Water Hazard classification notification

  • LEAP Campaign Creation

REACH:

• Co-ordinate a Monthly Meeting with all Euroapi Sites on current and potential REACH Registration and Regulatory Questions to ensure compliance.

• SIEF-Management: Communication with all EUROAPI Co-registrants and lead Registrant on LOA Cost, SIEF-Agreements contracts, Classification Clarification, Dossier updates, Reimurbsement and Joint Token.

• Liase with EUROAPI external legal (EY) on the SIEF-Agreements documents recieved and ensure REACH compliance are followed

• Communicate with EUROAPI Project Managers, R&D, manufacturing, supply chain, Site HSE and Site REACH Co-ordinators on REACH Regulations on compliance for non-EU countries suppliers and EU countries are met.

• Ensure that all REACH Inventories are up to date and all informations from the site REACH Co-ordinators, Project Managers such as Annex III, Analytical data and test data are stored on the SharePoint.

• REACH Expert engaging with all stakeholders such as ECHA, Regulatory bodies, suppliers, customers and SIEF members to ensure EUROAPI REACH obiligations are met.

• Provide expert knowledge on REACH Questions, Regulatory chemical compliance and ensure that all EUROAPI manufactured or purchased substances are following the Regulation.

• Creation of Standard operation procedure SOP

• Expert in managing REACH Submission

• Responsible for the following task

  • Trainings on REACH Topics

  • Joint Submission Dossier Creation and submission

  • Lead Registrant Dossier Creation and submission

  • Updates of REACH Registration Dossier

  • PPORD Submission

  • Inquiry Dossier Submission

  • Reimbursements calculations of co-registrant

  • SIEF Management

  • PPORD Submission

  • Coordination of ECHA Fees payments

  • Monitoring of REACH Compliance report for all sites

Requirements:

• Master of Science or equivalent in Environmental Toxicology

• Bachelor of Science or equivalent in Chemistry

• 10+ years’ experience in REACH, Safety data sheet and chemical compliance within the EU and other regions. With experience working as Senior consultant and Project Manager in Product stewardship and Regulatory affairs in the consulting industry.

• REACH Expert in compliance process and implementation such as only Representative, Inquiry Dossier, SIEF Management, Registration dossier creation and update.

• Experienced Project Manager in Chemical safety and Regulatory affairs projects

• Expert in Poison Center Notification CLP at ECHA and Australian Authorities

• Expert Knowledge in Global Chemical Compliance topics such as REACH, TSCA, DSL, NDSL and other chemical inventories.

• Dangerous Goods Regulation experience Due diligence Research for new country chemical regulation

• Expert in creation of Hazardous substance labels

• Classification and Labelling inventory Notification expert

• Environmental Toxicology Knowledge

• Effective communicator and exceptional team player in collaboration

Nice to have:

• Expert in Safety data sheet Creation via SAP and Lisam Software for different countries such as Europe, Switzerland, USA, Canada, Korea, China, UN GHS and other regions.

• Experience in delivering Training on Regulatory topics

• Effective communication and collaborations with various EUROAPI Sites

• Strong leadership skills with all Site Co-Ordinator to ensure compliance on REACH topics

• Lead sites on Global Regulatory Compliance Newsletter

• Provide comprehensive training to HSE Colleagues on Regulatory topics

Why join us?

• According to the company's Cafeteria policy, gross 636,000 HUF/year (also during the probationary period)

• Company bonus

• Health Care Program (Preventive screening tests once a year (laboratory, EKG, arteriography, internal medicine specialist examination), for which a paid day off is provided. On top of that free outpatient care throughout the year, also at the Buda Health Center.)

• Sports facilities (sauna, fitness room)

• Collective life and accident insurance

• Voluntary pension fund membership (supplemented with employer contribution)

• Free parking

• Office massage

About the company:

EUROAPI is a leading supplier of active pharmaceutical ingredients (APIs), spun out from Sanofi on May 6, 2022 and listed on EURONEXT, with the aim of becoming a global champion in API solutions and CDMO. The company has a diversified portfolio of approximately 200 APIs for its API Solutions business and its CDMO (Contract Development and Manufacturing Organization) activities. With more than 150 years of experience in the API market, around 3,350 employees and a consolidated turnover of approximately €1 billion in 2023, EUROAPI has six production sites and development centers equipped with state-of-the-art technology, all located in Europe (France, Germany, Hungary, Italy and the UK).