The Company
All candidates should make sure to read the following job description and information carefully before applying.
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.
T he 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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