Regulatory Specialist

Job Summary:
To provide specialist regulatory knowledge and support for chemicals to ensure the regulatory compliance of these materials for both internal and external customers. Learning the requirement of and supporting the CSCL regulatory business.

This role contributes to departmental revenue targets by ensuring the delivery of high-quality regulatory expertise.

As a Regulatory Consultant the role adds value to customers making Labcorp the best company to work with by proactively contributing to regulatory project management and delivery to a high standard.

Essential Job Duties:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

Main duties:
• Generation and submission of regulatory documents to a high standard that will include, but not be limited to:

• Learn and support the CSCL (30%)
  
  
  • Understand the regulation
  • Develop a strategy depending on the substance, advising at the enquiry stage
  • Liaise with clients and domestic laboratories
  • Understand the technical outputs from key study types
  • Negotiate outcomes and strategies with authorities
  • Dossier preparation and summary preparation

• Participate in scientific meetings and support to the team as required (10%)

• Support the EU, UK, KR REACh business in conjunction with the teams based in EU, UK and Korea. Understand the regulations and consult for registration work. Support for registration and post-registration clients in Japan (30%)
• Perform Web of Science JMAFF literature search and review. Investigation using the JMAFF specified database through the Web of Science and preparation of the literature review report. (20%)
• Dossier preparation for Chemical points in Agrochemical active/product registration. Understanding the requirements by JMAFF notification to prepare the dossier. (10%)

• Speaking: __Yes. Japanese, English - required
• Writing/Reading: ___Yes. Japanese, English - required

• At least 3 years with at least one year's experience specializing in an appropriate regulatory discipline
• Practical experience in preparing EU/ global regulatory applications and project managing complex regulatory projects in one of the three disciplines i.e. Chemicals, Biocides and Crop Protection.

• BSc/ Post-Graduate qualification and/ or PhD (relevant experience which may be substituted for level of education) in scientific discipline