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Summary: The Regulatory Manager will lead Summit Pinnacle Clinical Research's regulatory team, overseeing all regulatory activities, including submissions, site activation readiness, and timely approvals, from study initiation through close-out and archiving. This role collaborates closely with the operations leadership, VP of Compliance, and corporate stakeholders across medical affairs and finance to ensure successful completion of site regulatory activities.

Duties and Responsibilities:

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.
Participate in study start-up meetings and provide regulatory status updates to management.
Complete performance evaluations and conduct routine goal-setting and milestone meetings with direct reports.
Aid in data analysis and identify projects requiring additional support related to regulatory requirements

Duties, responsibilities, and activities may change, or new ones may be assigned at any time.

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.
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.

Knowledge, Skills, and Other Abilities:

Leadership and/or project management experience with the ability to work independently and collaboratively
Must be an energetic initiative-taker, results, and detail oriented, and possess the ability to work effectively with a customer-focused mindset.
Strong written and oral communication skills.
Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment.
Adept at critical thinking, problem-solving, and executing data-driven solutions with the ability to work well under pressure.
Superior organizational skills that include the ability to prioritize, delegate, direct, support, and evaluate others’ work and follow through on tasks and projects.
Strong team building skills to lead a highly productive team to accomplish short and long-term goals, both individually and organizationally.
Encourage a positive collaborative environment within the team and with stakeholders.
Lead by example and display a prominent level of integrity and professionalism.
Ability to provide and receive feedback in a constructive and helpful manner to elevate the success of colleagues and the organization.

Certificates and Licenses: Valid Driver’s License

FLSA Classification: This is an exempt position

Work Environment and Physical Demands:

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work is performed in an office and/or clinical environment.
Occasional domestic and/or international travel may be required.
Ability to work in an upright and/or stationary position for 6–10 hours per day.
Frequent mobility required.
Occasionally squatting, kneeling, or bending.
Light to moderate lifting and carrying (or otherwise moves) objects with a maximum lift of 20–50 lbs.

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