Regulatory Affairs Sr. Specialist

Operational Support Support operational activities and monitor adherence to defined policies, procedures, and instructions. Assist in identifying operational issues, recommend solutions and escalate matters when required.. Quality & Compliance Monitor work quality and support compliance with defined standards and requirements.

Review outputs and report deviations to ensure corrective actions are taken. Team Support Provide technical guidance and support to team members within the area of expertise.Facilitate on-the-job training and provide guidance through task coordination and support.

Coordinate Coordinate activities between team members and management to ensure alignment and workflow continuity. Facilitate clear communication and follow up on agreed actions to support effective execution.

Job-Specific Accountabilities Regulatory Compliance Management Monitor and interpret applicable regulatory requirements, standards, and licensing obligations affecting Badael’s products and operations across relevant markets. Assess regulatory compliance processes and controls, identifying gaps and supporting corrective actions.

Ensure regulatory requirements are incorporated into relevant product, marketing, distribution, and operational activities. Regulatory Submissions and Documentation Coordinate regulatory filings, registrations, approvals, permits, licenses, and certifications for Badael’s products and operations.

Track and manage submission, renewal, and approval timelines to support timely product availability and market continuity. Maintain accurate and audit-ready regulatory records, submissions, approvals, and correspondence. Collaboratewith relevant functions to ensure submissions are complete, accurate, and timely.

Legislative Monitoring and Impact Analysis Monitor and assess regulatory and legislative developments affecting Badael’s products, operations, and market access. Review regulatory changes and assess their potential business implications and required actions.

Support regulatory guidance and recommendations on compliance, risk mitigation, and business decisions. Prepare regulatory analyses and briefing materials on significant regulatory developments. Internal Advisory and Stakeholder Engagement Provide regulatory guidance to internal stakeholders on applicable requirements and regulatory developments.

Collaborate with relevant functions to integrate regulatory requirements into products, projects, and business activities. Facilitate awareness of key regulatory requirements and changes affecting Badael. Regulatory Authority Engagement Support Badael’s regulatory engagements with authorities on relevant non-scientific matters.

Maintain effective working relationships with relevant regulatory authorities and external stakeholders. Coordinate regulatory consultations, inquiries, and requests, ensuring timely follow-up and resolution.

Risk Management and Continuous Improvement Identify regulatory risks affecting compliance, product approvals, and market access, and support appropriate mitigation actions. Track regulatory findings and corrective actions to support timely resolution.

Review regulatory processes, tools, reporting, and documentation, and recommend and implement improvements to enhance efficiency and consistency.