Regulatory Manager

Regulatory

Maintain confidentiality and ensure compliance with applicable regulations and guidance, including FDA, ICH GCP, HIPAA, IRB requirements, and corporate policies and procedures.

Oversee regulatory documentation management, ensuring all policies and procedures are current and compliant, and establish standard procedures for managing documents within the company's platform.

Provide subject matter expertise on regulations and their applicability to specific study requirements; collaborate with clinical operations and medical affairs on regulatory matters.

Lead regulatory start-up activities in alignment with study timelines; prepare, review, and submit initial regulatory packages (e.g., Protocol Signature Page, Investigator Brochure Acknowledgment, Financial Disclosure Form, Form FDA 1572).

Direct staff to manage initial Informed Consent updates, including stipend language and edits required prior to IRB submission; maintain the eISF throughout the study.

Oversee regulatory submissions, provide guidance on submission requirements to direct reports, and lead document preparation for monitoring visits, audits, and inspections.

Facilitate development and review of regulatory standard operating procedures.

Collaborate with the VP of Compliance on protocol deviation reporting.

Proactively identify, manage, and escalate study-related regulatory issues; provide accurate and up-to-date metrics to management.

Coordinate multiple projects with competing priorities across varying study volumes and timelines.

Ensure backup coverage for continuity of regulatory operations.

Team Leadership and Administration

Supervise the regulatory team in accordance with the organization's policies and applicable laws.

Train employees, assign and direct their work, evaluate performance, address complaints, and resolve problems.

Manage, mentor, and professionally develop direct reports; identify training needs, implement improvements, and ensure all staff maintain current training documentation.

Define and manage project resource needs within specified timelines and budgets; identify department staffing, supply, and equipment needs.

Track key study metrics, including submission and approval milestones, using CTMS and other tools; maintain documents, databases, and spreadsheets to identify deficiencies and improvement opportunities.

Aid in data analysis and identify projects requiring additional support related to regulatory requirements.

Qualifications

Bachelor’s or advanced degree with at least 4 years of clinical research experience, with a focus on regulatory responsibilities preferred.

We may also consider candidates who have an appropriate combination of education and experience.

At least 2 years of supervisory experience preferred.

Must have strong knowledge of FDA regulations and ICH/GCP guidelines.

Must have strong knowledge of regulatory document management requirements.

Must have excellent interpersonal, written, and verbal communication skills, administrative skills, and computer fluency.

Possess proficient in all Microsoft Office applications.

Must complete GCP training during onboarding and maintain certification.

Possess impeccable integrity and personal and professional values that are consistent with Summit Pinnacle’s high standards.

Comply with the company policies, code of ethics, and guiding values.