Regulatory Affairs Operations Specialist
Regulatory Affairs Operations Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Bachelors degree (scientific or related discipline preferred).
Minimum 5 years of experience in a regulated environment (pharma biotech medical devices etc.).
Required Skills
Technical Proficiency: Word processing spreadsheets databases and online research tools.
Regulatory Knowledge: Understanding of applicable regulations and compliance requirements.
Organizational & Project Management: Ability to manage multiple projects and deadlines efficiently.
Communication & Collaboration: Strong written/verbal skills; adept at negotiation and teamwork.
Problem-Solving: Ability to identify compliance risks and escalate/resolve issues effectively.
Attention to Detail: Ensures accuracy in documentation and regulatory submissions.
Independence: Works with minimal supervision while contributing to cross-functional projects.
Under limited supervision the Regulatory Systems Specialist is responsible for implementing regulatory strategies resolving submission-related issues and ensuring compliance with regulatory requirements.
Key duties include:
Documenting system issues identifying resolutions and managing complex process documentation.
Supporting system upgrades to ensure data integrity and proper functionality of tools/version updates.
Maintaining electronic records receipt and submission systems for regulatory authorities.
Collaborating with project teams to provide expertise on compliance and system solutions.
Monitoring regulatory changes assessing potential impacts and mitigating compliance risks.
Employment Type
Full-time
