Our client, an innovative chemical science company who are now expanding their R&D pipeline to support their global growth, have a number of exciting opportunities in their Regulatory team for scientists who wish to put their knowledge and training to use in a fast-paced, results-focused commercial R&D environment.
As part of their expansion, our client now seeks a Regulatory Specialist, Residues and Analytical Development
to join their Regulatory team assisting with the defence of existing product authorisations through the renewal process. The Regulatory Specialist, Analytical Development role will be responsible for the design and troubleshooting of residue trials, metabolism studies and analytical methods supporting these studies.
Profile: preferred candidates will be performance driven, with a 'can-do' attitude and ability to work in fast paced evolving environment. Demonstrated ability to work on own initiative or as part of a team, in meeting strict timelines is necessary.
Candidate with significantly strong regulatory experience in this area, who is deemed a fit with this role will have flexibility to work remotely / from home office.
Responsibilities of Regulatory Specialist, Residues and Analytical Development:
- Calculation of input values and conducting risk assessments for consumer exposure using relevant EU (e.g. PRIMo) or national models.
- Design and troubleshooting of residue trials, metabolism studies and analytical methods supporting these studies.
- Data gap analysis for active substances and products.
- Collation of information from various sources in order to prepare logical and coherent reasoned case arguments.
- Compilation and review of draft registration reports, with a particular emphasis on residues and analytical methods sections.
- Liaison with Member State regulatory authorities, consultants, CROs, test facilities and other internal departments (e.g. laboratory).
Requirements for Regulatory Specialist, Residues and Analytical Development:
- Bachelor of Science Degree at minimum in Life Science discipline. Masters or PhD being an advantage.
- 2+ years experience in regulatory affairs, within chemical science and/or plant protection industrial setting.
- Experience working with residues, analytical method development and associated validations is highly desirable.
- Proven ability to present clear and concise written arguments to support a specific regulatory or scientific position on a topic.
- Perform tasks in an accurate, timely and efficient manner.
- Excellent attention to detail is a must.
- Excellent organisational skills with the ability to multi-task and work in an environment with shifting priorities.
- Proactively seek to add value to processes, both existing and new.
- Proficiency in Microsoft Word, Excel, PowerPoint.
- Proficiency in an EU language (French/German/Spanish/Italian) would be an advantage.
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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