Snr Reg Affairs Scientist – Remote Working

Smithers ERS Limited is a member of the Smithers Group and is recognised as a leader in delivering trusted testing services.

The business performs environmental and consumer safety contract research and regulatory services for the crop protection, pharmaceutical, industrial chemical, and the consumer product industries. Smithers ERS has performed standard guideline and higher-tiered environmental studies for over 45 years and conducts studies to satisfy all regulatory requirements globally.

Key offerings include environmental fate, plant and animal metabolism, aquatic and terrestrial ecotoxicology, honeybee and pollinator testing, avian toxicology, residue, analytical, and product chemistry, and regulatory risk assessment.

Within our UK site, the need has arisen for a Regulatory Affairs scientist with expertise in Pharmaceutical Environmental Risk Assessment to join the team in Harrogate. The business is privately owned, highly entrepreneurial, relationship-driven and would provide a solid platform to further develop your skills and knowledge.

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Reporting directly to the Managing Director, you will be responsible for the preparation of regulatory submissions for pharmaceutical environmental risk assessments in Europe, US and other geographies as required.

You will have responsibility for client management and retention with an ability to provide regulatory advice and contribute to submission strategy. May act as scientific mentor to provide regulatory advice and input into study design to other members of staff including Study Directors.

Role/requirements

• Experienced in conducting environmental risk assessments across a range of industries , but particularly pharmaceutical ERAs.
• Experience in the preparation of expert reports, waivers and regulatory rebuttals.
• Strong project management skills – providing proactive project updates to clients, and demonstrating effective dissemination of information to all staff involved in the project.
• Concise and effective verbal and written communication skills with internal and external personnel.
• A genuine passion and strong track record of meeting the needs and requirements of a customer, from start to completion and beyond.

You must possess highly developed interpersonal skills and be able to demonstrate previous experience of working in a fast-paced environment along with the ability to be a collaborative influencer and proactively drive decision making within projects.