Job Description

Title: Regulatory Affairs Ops Specialist

Pay: $37-$45.50

Type: Hybrid

Duration: 12 months

Key Responsibilities:

• Under limited supervision responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions.
• Produces and evaluates technical and scientific data necessary for regulatory submissions.
• Assists in the implementation and delivery of new or upgraded systems and processes in support of companies products.
• Document all system related issues, and identify resolutions
• Document complex processes and create and manage documentation related to validated systems
• Participate in identifying solution to meet requirements for systems - Participate in system upgrades to assure integrity of data is maintained
• Assure adequate access and functioning of system tools and version upgrades - Provides expertise in ongoing maintenance of electronic record receipt and submission to regulatory authorities
• Participate as an active team member and provide expertise to project teams as required
• May verify the maintenance of support systems, libraries and dictionaries - Maintain awareness of regulatory requirements and evaluate potential impact to company

Qualifications:

• Bachelor's Degree or country equivalent with a minimum of 5 years in a regulated environment.
• Scientific or related discipline would be an advantage.
• Detail oriented
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Written and verbal communication skills
• Knowledge of applicable regulations
• Excellent organizational skills and ability to support multiple projects
• Ability to contribute to multiple projects from an operations perspective
• Work independently with minimal direct supervision
• Strong negotiation and collaboration skills
• Manage multiple projects and deadlines
• Ability to identify compliance risks and resolve or escalate when necessary
• Experience in addressing complex problems or processes

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