Job description

Responsibilities:

• Support international product submissions (new registrations, re-registrations, and renewals) and tender responses by compiling required product documentation.
• Collect international regulatory impact assessments for anticipated changes as well as change control responses.
• Coordinate timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sales, and Certificates of Exportability. Interface with applicable regulatory agencies and international consulates.
• Prepare requests for Legalization and Apostille for international registrations. Serve as departmental notary.
• Create reports for communication to client leadership on regulatory activities. Track and compile regulatory metrics for reporting to management.
• Support regulatory operational systems and ongoing maintenance.
• Tracks and maintains required licenses, facility registrations, and listings to ensure regulatory compliance.
• Manage departmental communications, inbox/distribution lists, SharePoint/MS Teams sites, intranet site, and memberships.
• Maintains regulatory databases/filing of regulatory documentation including regulatory strategies, change notifications and responses, letters-to-file, etc. within the scope of record retention requirements.
• Organizes audit preparation documentation to support internal/external client audits.
• Assists in the compilation/assembly of regulatory submissions.
• Facilitate contracting, processing of invoices/creation of purchase orders, and expense tracking for third party vendors. Provide status updates of budget spend, as necessary.
• Additional duties as assigned.

Requirements:

• BS, B.Sc., BA university degree in a technical or scientific discipline or cumulative related work experience. Alternative education with related work experience may be considered.
• Prior experience working in regulated industry.
• Proficient in using Microsoft suite (i.e., Word, Excel, PowerPoint).
• Strong communication and project management skills.
• Must be able to handle multiple tasks.
• Public notary preferred.

Job Types: Full-time, Contract

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Remote: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: In person

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