Immediate opportunity open for a Regulatory Affairs Specialist to work in St. Louis, MO. Our client for this position is one of the world's largest life science companies, focusing in agricultural, healthcare, and pharmaceutical research.
As the successful candidate, you will assist the PCL (Product Chemistry Lead/Manager) to execute standardized functions that will enable the PCL to focus on leading and managing the compliance, workflows, Technical Grade Active Ingredient (TGAI), agency and industry processes and improvements. You will enable Registration Managers in Environmental Science (ES) and Crop science to focus on the management of their products with EPA, by taking on administrative tasks using our client's internal computer aided processes to support local and global product compliance (CHAMP, RegPrime, co-formulants) needs.
- Receive the product composition change request from the global organization and coordinate the change process from planning to submission with registration manager and product chemistry manager/lead and update the appropriate supporting systems (CHAMP, RegPrime, DART, BRIDG and other)
- Generate the Confidential Statement of Formula (CSF) and support Product Chemistry documentation for submission to EPA composition changes or new products for the Crop and Environmental Science supporting USA business needs.
- Manage and organize data relevant for the creation of CSFs
- Convert CSF documents into deconstructed data, to realize the full benefit of the data in the BRIDG system and aid in driving future efficiencies
- Serve as a reviewer for CSFs and product chemistry reports to ensure compliance with our production documents
- Perform periodic audits of current specifications vs what we understand to be current, and specifications vs the current CSF.
- Foster and support change management to implement the new and enhanced systems for error reduction and compliance.
- Serve as the backup PCL for USA/NA
Working hours: 8:00 AM - 5:00 PM
- Apply technical know-how to regulatory product chemistry related projects
- Manage and lead multiple tasks in a very complex environment with changing priorities and timelines.
- Strong attention to detail, commitment to accuracy and confidentiality.
- Communicate well and clearly with different levels of management hierarchy and with different business partners with diverse backgrounds.
- Liaise with required business partners and work independently;
- Learn new tools and data systems (internal and external) by partnering with cross-functional/global teams and regulations pertaining to product chemistry and CSFs.
- Apply strategic thinking/planning for process improvements/agency data simplification; recommend hyper-automation projects to digitalize current workflows.
- PhD with minimum of 3 years relevant experience or MS with minimum of 5 years relevant experience or BS with minimum of 7 years relevant experience
- Chemistry background (preferred in the pesticide or equivalent business)
- Profound computer skills (experiences working with databases) with foresight to improve workflow operations
This is a great opportunity in a positive, innovative work environment where all workers are treated with respect and diversity is accepted.
Benefits provided by Randstad include medical, dental, vision insurance; 401k; and holiday pay.
Relocation cost reimbursement is not available for this position.
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