Senior Regulatory Compliance Officer

The Senior Regulatory Specialist serves as the primary contact for investigative sites during site start-up activities and maintenance, ensuring timely collection of required documents and submission to regulatory authorities.

This role proactively interacts with regulatory authorities to provide guidance on requirements and maintains awareness of current regulatory standards.

Key Responsibilities:

• Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
• Coordinate and collect data and information required by regulatory authorities, including preparation of study documentation.
• Compile and prepare routine submissions filed to regulatory authorities and liaise with them regarding submission/approval.
• Liaise with internal and external vendors in the generation of regulatory authority submissions.
• Perform review of final submission documents.
• Ensure all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget, and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
• Prevent and escalate study issues appropriately and in a timely fashion.
• Perform other duties as assigned by management, depending upon country and situational requirements.

In-Country Specific Tasks:

• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
• Collect and track necessary documents and perform quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance.
• Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis, making ready for an audit at any time.
• Participate in team and project meetings as applicable.
• Assist in strategy definition for Site Activation and provide accurate projections and timelines to study teams.
• Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol.
• Proactively resolve informed consent issues and other potential difficulties with study sites.
• May support negotiation of site contracts and budgets with sites, if applicable, and track progress of contract and budget milestones/developments.
• Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.

Clinical Trials Information System (CTIS) Tasks:

• Assist in upload of submission documentation to CTIS and interact with and monitor notifications and alerts to ensure all milestones and events for the trial are met within mandated timelines.

Regulatory Expertise:

• Thorough knowledge of regulatory legislation, guidance, and practice in assigned countries.
• Ability to maintain awareness of current regulatory standards and adapt to changes.

Communication and Interpersonal Skills:

• Excellent communication and interpersonal skills to effectively interact with regulatory authorities, internal and external vendors, and study teams.
• Ability to negotiate site contracts and budgets as needed.

Organizational and Time Management Skills:

• Strong organizational and time management skills to coordinate and manage multiple tasks and deadlines.
• Ability to prioritize tasks and allocate resources effectively.

Professional Growth and Development:

• Opportunities for professional growth and development through training, mentorship, and exposure to new challenges.

Collaborative Work Environment:

• Collaborative work environment that fosters open communication, teamwork, and mutual respect.

Recognition and Rewards:

• Recognition and rewards for outstanding performance and contributions to the organization.

Adaptability and Flexibility:

• Ability to adapt to changing priorities, regulations, and technologies.
• Flexibility to work in a dynamic environment with varying demands and deadlines.