Regulatory Affairs Specialist

Required Education

• Bachelor’s 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.