Regulatory Specialist (scientific/food)

My Client is a global leader in the manufacture of thermoplastic masterbatch, plastic & polymer products, & I am currently looking to add to their Regulatory Team for a Maternity Leave 12 month contract, working with the Regulatory, Quality and IP Departments.

The Regulatory Department is responsible for setting the operating framework & compliance with applicable chemical safety, chemical inventory, labelling, and food contact laws in the regions in which their products are sold. With additional responsibility for tracking legislative changes, maintaining information on legal compliance for all raw materials, and preparing the necessary documentation for customers.

What will your new role look like?

As Regulatory Specialist, you will provide regulatory support & technical knowledge to ensure that regulatory requirements are fulfilled and maintained to support new and existing technologies. This involves compilation of technical dossiers for submission to regulatory authorities to gain approval for use of novel chemistries in food contact applications and appropriate coordination of analytical and toxicological data.

What accountability will you have as Regulatory Specialist?

• Understanding, mastering and applying food contact legislation and reviewing new chemistry types for compliance (i.e. packaging requirements):
  • Europe
  • USA (FDA)
  • Asia
  • Mercosur

Understanding, mastering and applying chemicals legislation, and reviewing new chemistry types for compliance:

• • Classification and labelling
  • REACh
  • BPD
  • Global chemical inventories

Overseeing document generation for customers with support of Regulatory Coordinator i.e.

• MSDS
• Declarations of compliance with food contact legislation, heavy metals legislation, absence of specific hazardous chemicals.

• Dealing with non-routine complex customer enquiries, customer questionnaires, migration data requests, legislative explanations. Escalating issues to Regulatory Manager as required in a timely manner and seeking assistance if required.
• Reviewing the impact on finished goods compliance status when there are changes in the status of raw materials, coordinating discussions with relevant parties to collectively decide an appropriate path forward (e.g. reformulation, communicate change to customers etc.).
• Reviewing new chemistry types for compliance with the legislation's listed above.

• Assisting with compilation of technical dossiers for submission to regulatory bodies to gain approval for use of material in food contact applications.
• Supporting REACH registration of chemicals and development of strategies for REACH registration (i.e. cost/benefit analysis and data gap analysis).
• Provide project support as required related to data management for existing materials (i.e. migration data collation, toxicological data collation).
• Provide project support as required to support the business in adhering to new chemicals legislation (i.e. GHS, new chemical inventory notification requirements).
• Providing adequate regulatory support and resource to selected strategic business projects delegated by Regulatory Manager, including collation of technical and regulatory data to support business activities as required.
• Reviewing and approving COSHH assessments. Supporting Regulatory Coordinator with COSHH assessments for any new trial materials.
• Act as main point of contact with brand owners for new product approvals, manage approvals processes, responding to queries and following up as necessary.

Responsibilities

• Assisting in addressing legislative developments and supporting the Regulatory Manager as required.
• Liaising with third party laboratories to coordinate purity testing and migration studies and other evaluations as needed.
• Interpreting and reviewing analytical data and toxicological data with regard to suitability for use of chemicals in food contact applications.
• Assisting in compilation of technical dossiers for submission to regulatory bodies to gain approval for use of material in food contact applications.
• Compiling technical reports for both internal and external use related to:

Technical effects of materials

Regulatory status (Chemical inventories and Food Contact)

Migration from polymer substrates

Toxicological and exposure data

Purity data

• Supporting Raw Material Regulatory Coordinator in reviewing supplier's regulatory paperwork and liaising with supplier to fill any gaps and query discrepancies.

• Completing non-routine complex customer enquiries, or supporting the regional regulatory coordinator to complete, as required.
• Managing data in SAP EHS module and supporting regulatory coordinator with generation of MSDS'.
• Managing communications with internal and external customers regarding the regulatory status of finished products.
• Producing documentation as required answering customer enquiries.
• Other duties as assigned or needed.

Qualifications & Experience Required

• Degree in a scientific discipline, with a strong background in Food Contact legislation (EU PIM 10/2011, FDA 21 CFR).
• Suitable candidates should also have experience of one or more of the following, compilation of dossiers for submission to either EFSA or FDA, REACH strategy management, report writing, migration testing and migration modelling from packaging to food stimulants.
• Knowledge of GHS and classification and labelling would also be an advantage.
• A good understanding of analytical chemistry techniques and also a basic understanding of key toxicological principles is also required.
• Previous experience where effective multi-tasking is required.

This role is a Maternity Leave role lasting a minimum of 12 months starting mid/end October.

If interested, please click apply now or call me to discuss

Jayne 07484044731