Job Summary:
To provide specialist regulatory knowledge and support for chemicals, biocides and agrochemicals to ensure the regulatory compliance of these materials for both internal and external customers.
The role contributes to departmental revenue targets by ensuring the delivery of high quality regulatory expertise.
As a regulatory specialist 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.
Individual Contributor
C. 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.
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Principle duties:
¨ Generation and submission of regulatory documents to a high standard that will include, but not be limited to
- Preparation and submission of regulatory (technical) dossiers (20%)
O Study Summaries- Prepare study summaries from current guideline study reports compliant for multiple regulatory disciplines including, but not limited to IUCLID RSS for REACH/BPR and Tier 1/2 OECD summaries for ag chem. (15%)
O Risk assessments- Understand and use basic exposure models to develop exposure scenarios and generate risk assessments using tools accepted by regulators (7.5%)
O Data gap analysis- Contribute to assessment of data for suitability to use in regulatory submissions. Advise on data gaps to fulfil standard information requirements (7.5%)
¨ Regulatory Project Management: Manage non-complex regulatory projects and/or programs. Demonstrate effective communication with customers both in writing and verbally to deliver regulatory projects to agreed regulatory and business targets (15%)
¨ Regulatory & scientific advice to customers (consulting & testing): Provide customer advice on regulatory processes and requirements for registration programs with support/ peer review by regulatory personnel (5%)
¨ Authority contact- Communicate effectively both in writing and verbally and with good level of understanding of regulatory requirements in order to seek clarification from authorities (5%)
¨ Proactively keep up to date with regulatory requirements and developments, as directed by Supervisor (5%)
Operational/ project support duties
¨ Operational project management (not customer related) - adhere to departmental time recording process, with supervision organize own project planning and time management to allow budget tracking and delivery of project requirements to be met (10%)
¨ Commercial awareness- Adhere to project targets and record project hours within time allowed for regulatory task raising any shortfalls to Project Leads (5%)
¨ Attendance at internal/external training courses may be required with a view to providing feedback to the rest of the department, in the form of a presentation (5%)
G. Language Skills Required:
- Speaking: English (required)
- Writing/Reading: English (required)
Experience:
Minimum Required:
Years of experience in the job discipline: Minimum 1 years' experience working in regulatory affairs
Years of experience in other professional roles: None specified
Other required work-related experiences: None specified, but customer service role is an advantage.
III. Education/Qualifications/Certifications and Licenses
Recommended:
Level of education: BSc in scientific discipline. Relevant experience may be substituted for preferred level of education
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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