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Regulatory specialist

Ashington
MTrec Technical
Posted: 18 June
Offer description

Job Description

The Company

Our client is a specialist in the manufacturer for the pharmaceutical sector. Due to growth, they are now looking to recruit a Regulatory Specialist.

The Role

* Manage and maintain EU, GB and EMEA authorisations of biocidal products; ensure compliance with other chemical regulations where applicable e.g. CLP; manage and maintain transitional biocidal registrations.
* Submission, maintenance, changes and renewals for products under EU BPR, GB BPR and other EMEA regulations as per market requirements.
* IUCLID dossier build, use of R4BP, preparation of SPCs, submission of IUCLID dossiers, preparation and submission of Poison Centre Notifications.
* Supporting Quality Assurance with implementing regulatory changes e.g. label artwork and Change Controls.
* Providing regulatory input for SDS preparation, marketing, sales, technical and R&D.
* Attend regulatory meetings in EU and elsewhere as required.
* Regulatory monitoring, including awareness of new regulations and changes to existing regulations, including internal communication of any potential impact to the company.
* Maintain compliance with other chemical regulations e.g., REACH, CLP, Detergents, as applicable for product range.
* Submission of annual biocidal product sales quantities to selected Member States.
* Liaise with all departments, project teams, suppliers, testing laboratories, distributors, consultants and Member State Competent Authorities to co-ordinate and monitor regulatory submissions and requirements
* Support other group sites with global disinfectant registrations.
* Could be full time or part time depending on the person.
* Could also offer remote working but site visits at least once a month or expected.

The Person

* Will have experience within a similar role.
* Must have biocides and BPR experience.
* You will have good IT Skills (Word, PowerPoint and Excel).
* Be proficient in use of IUCLID and R4BP.
* Good scientific communication (written and oral).
* Experience with human health toxicology and environmental risk and exposure assessments would be desirable.
* Experience with efficacy testing for regulatory purposes is desirable.
* Experience with CLP, REACH, SDS authoring and regulatory labelling would be beneficial.

The Benefits

* Discretionary annual bonus.
* Private Medical Insurance for you and your family.
* Pension Scheme.
* Corporate benefits platform and Cycle to Work Scheme.
* Death in Service Benefit.
* Remote or part time working.


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