Regulatory Specialist

Responsibilities:
Standard Operating Procedures (SOPs):

• Develop and execute comprehensive SOPs to ensure strict adherence to protocol requirements and maintain the highest standards of practice, while guaranteeing full compliance with Good Clinical Practice (GCP) standards.

Training Programs:

• Formulate and implement robust training programs for the clinical team, thereby enhancing their understanding of compliance protocols and ethical considerations.

Auditing and Monitoring:

• Conduct meticulous audits and internal monitoring of selected research protocols to mitigate compliance discrepancies.

Compliance Training:

• Develop and deliver engaging training sessions that foster awareness and education regarding compliance protocols for the clinical team.

Process Optimization:

• Develop and implement streamlined processes to enhance operational efficiency and ensure timely reporting.

Regulatory Compliance Strategy:

• Devise and implement a comprehensive regulatory compliance strategy for clinical trials across diverse therapeutic areas.

Regulatory Guidance:

• Provide expert regulatory guidance on clinical trial protocol implementation and regulatory submissions.

Risk Assessment and Mitigation:

• Anticipate and assess potential regulatory risks and develop effective risk mitigation strategies.

Regulatory Compliance Training Program:

• Develop, implement, and continuously update a comprehensive regulatory compliance training program to ensure that staff remains current with the latest regulatory compliance requirements in clinical research.

Compliance Audits and Documentation:

• Conduct thorough compliance audits on select clinical trials and meticulously document regulatory compliance.

Regulatory Compliance Assurance:

• Ensure that all clinical trials adhere to applicable regulatory requirements, including ICH GCP guidelines, FDA regulations, EMA guidelines, and other relevant international standards.

Regulatory Change Monitoring:

• Monitor changes in regulatory requirements and communicate their implications for ongoing and future clinical trials.

Collaboration with Clinical Operations:

• Collaborate closely with Clinical Operations to ensure unwavering adherence to regulatory standards and best practices.

Regulatory Expertise and Document Development:

• Provide expert regulatory guidance and contribute to the development of essential clinical and regulatory documents (e.g., source documents, training manuals, clinical study forms, and metric reports).

Global Regulatory Awareness:

• Remain current on global regulatory trends, guidance, and industry practices.

Formal Communication:

• Prepare professional communications, such as memos, emails, reports, and other formal correspondence.

Document Preparation and Editing:

• Write and edit a variety of documents, ranging from letters to comprehensive reports and instructional documents.

Filing System Management:

• Establish and maintain a well-organized filing system, encompassing both electronic and physical records.

Note to Files (NTFs) and Corrective and Preventive Action Plans (CAPAs):

• Create comprehensive NTFs and CAPAs to meticulously document critical information, decisions, and actions related to clinical trials, regulatory submissions, and other pertinent activities.

CAPA Implementation:

• Develop and implement CAPAs to address identified issues, deviations, and non-conformances, thereby ensuring compliance with regulatory requirements and company procedures.

NTF and CAPA Record Management:

• Maintain accurate and up-to-date records of NTFs and CAPAs, facilitating easy access and retrieval for future reference and audits.

Clinical Team Support:

• Assist the clinical team in research endeavors by facilitating the protocol approval process and maintaining meticulous documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.

Study Completion Processes:

• Assume responsibility for study completion processes, including data lock, study closeout, reporting, and archiving of study files, ensuring the completeness and continuity of all study data. Conduct ongoing checks of clinical/translational data entered on case report forms (paper or electronic) or in reports and ensure archival of appropriate/required documentation.

IRB Compliance:

• Support processes and monitor practices to ensure that regulatory documentation related to clinical trials complies with Institutional Review Board (IRB) policies, procedures, and regulations.

Safety Reporting:

• Demonstrate comprehensive knowledge of the safety reporting requirements outlined in the study protocol, FDA regulations, and other relevant regulatory bodies.

Regulatory Document Completion and Maintenance:

• Complete and maintain regulatory documents for all study personnel, including curriculum vitae, licenses, bio-sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs.

Regulatory Binder Management:

• Compile and maintain comprehensive regulatory binders (paper or electronic).

Submission Applications and Documentation:

• Complete submission applications and other required documentation, and prepare protocol-specific forms for submission to the IRB and sponsoring entities.

Site Activation Preparation:

• Prepare DOA, training logs, and other necessary items for site activation and throughout the study conduct.

Meeting Coordination:

• Schedule and coordinate staff and other meetings for training purposes.

IRB Query Management:

• Address and submit any queries or clarifications from IRB organizations.

Adverse Event (AE) and Serious Adverse Event (SAE) Reporting:

• Assist in compiling AE, SAE, and/or PD reports with the clinical trial team and submit to the IRB, as applicable.

Requirements:

• Bachelor's degree in life sciences, pharmacy, or a related field.
• 2-5 years of experience in Quality Assurance (QA)/Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on clinical trials.
• Regulatory Strategy and Submission Expertise, Demonstrated experience in leading regulatory strategy and submissions for clinical trials across multiple trials.
• In-depth knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
• Strong leadership skills with experience in managing and developing teams.
• Excellent communication, negotiation, and project management skills.
• Ability to work effectively in a fast-paced, cross-functional environment.
• Proven ability to manage multiple projects and meet deadlines.
• Please note that due to the immunocompromised nature of our patients, annual flu vaccinations are required.