3rd Party Global Regulatory Specialist
Kelly Outsourcing Consulting Group Kelly OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a 3rd Party Global Regulatory Specialist for a long-term engagement at one of our premier agricultural science clients in Newark, DE.
Schedule: Monday-Friday, 1 st shift (8AM-4:30PM)
Location: Hybrid, Mon/Tues/Wed onsite in Newark DE & Thurs/Fri Remote
Compensation: $22.00/hr
Duration: 1yr contract, can extend
SUMMARY
The Third Party Global Regulatory Specialist supports the Global Regulatory Affairs, Science and Strategy team by managing documentation activities for third-party product registrations. This role reports to the Global Regulatory Documentation Manager.
RESPONSIBILITIES
Serve as the primary liaison between company and third-party stakeholders to coordinate and process regulatory documentation required to support third-party product registrations.
Manage third-party document requests in accordance with established timelines, compliance requirements, and contractual obligations.
Apply principles of responsible care and product stewardship to ensure strict confidentiality is maintained between company and third parties, as well as among individual third-party partners.
Provide clear, timely, and accurate communication to third parties regarding document status, progress, and any changes to requirements.
Partner with Country Regulatory Managers (CRMs) to confirm documentation aligns with local regulatory requirements and support the accurate submission of confidential documents to regulatory authorities on behalf of third parties.
Utilize company and third-party SharePoint sites, as well as RegOne, to manage, track, archive, and retrieve regulatory documents efficiently.
Maintain and update regulatory document templates using the most current approved information, ensuring Letter of Access templates remain aligned with applicable third-party agreements.
Collaborate with internal and external stakeholders to validate document requirements, including assessment of country watch lists and global expansion or infringement considerations.
Coordinate document requests with third-party partners to support regulatory submissions, including ongoing collaboration with designated external contacts.
QUALIFICATIONS
Bachelor's degree in Biology, Chemistry, or a related scientific discipline, or equivalent combination of education and relevant experience
Demonstrated commitment to maintaining confidentiality and handling sensitive information.
Understanding of regulated environments and the importance of adherence to approved processes.
Proven project management and multitasking capabilities, with the ability to manage competing priorities effectively.
Strong written and verbal communication skills, with the ability to work effectively across cultures and with external partners.
Excellent planning, organizational, and attention-to-detail skills.
Proficient in Microsoft Outlook, SharePoint, Word, and Excel; comfortable learning and working within multiple database systems.
Ability to work independently, prioritize workloads, and consistently meet or exceed established timelines.
Experience working under tight deadlines and adapting to changing business needs.
Demonstrated ability to influence and collaborate with others to achieve shared objectives.
Strong team-oriented mindset, with experience working in cross-functional and globally distributed teams.
Commitment to continuous improvement, professional development, and process optimization.P#1Send Resumes to Jacqueline.Sayoc@KellyScientific.com
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