Senior Manager, Regulatory Affairs

About Us:

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.

Title: Senior Manager, Regulatory Affairs

Compensation: $120,000 - $150,000 per year depending on experience and qualifications

Status: Full-time, 40 hours

Location: Chandler, AZ (On-site)

Reports to: Director of Regulatory and Compliance

Essential job functions/duties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Aid the Director of Regulatory and Compliance with implementing compliance policies and procedures to ensure adherence to applicable law, regulations and industry standards.
• Help develop annual goals/tactics for the department that aligns with business strategies and execute through collaborative means.
• Conduct/Assist in regular audits and assessment to identify potential compliance risks and develop strategies to mitigate them.
• Provide guidance and training to employees on compliance and regulatory related matters.
• Stay updated on changes in laws and regulations related to healthcare compliance and communicate relevant information to the organization.
• Oversee the preparation and submission of regulatory filings.
• Collaborate with cross-functional teams to provide regulatory guidance and support.
• Represent the company in interactions with regulatory authorities.
• Lead training programs to enhance staff knowledge and adherence to quality compliance.
• Stay updated on industry trends and best practices, and proactively recommend process enhancement to optimize quality assurance best practices.

Knowledge/Skills/Abilities Required:

• At least five (5) years of Regulatory experience and/or quality assurance and quality control experience required
• At least five (5) years of team leadership experience, preferably managing managers required
• At least five (5) years of clinical research experience in a compliance role, managerial role, coordinator role, or related preferred.
• High understanding of clinical research protocols, regulation, and compliance.
• Ability to make good judgement and decisions regarding business strategies that affect the department.
• Ability to work independently with little supervision.
• High organizational skills and attention to details.
• Knowledgeable in IRB procedures and compliance
• Great interpersonal communication skills both in writing and verbally.
• Ability to assess and minimize risk for the clinical research program.
• High sense of business acumen.

Supervisory Responsibilities: (4 direct reports)

• Regulatory Manager (Regulatory Team)
• Quality Assurance Manager
• Quality Control Manager
• Study Start-Up Specialist
• Ensure timely evaluations for direct reports
• Coach and mentor team members as necessary to expand growth opportunities and professional development
• Set and document performance metrics with each department leader
• Document performance issues and coach/guide direct reports as needed
• Hire and ensure proper training of new team members

Travel requirements:

• Some interoffice travel may be required with use of company vehicle or mileage reimbursement

Education, credentials, and/or trainings:

• Bachelor's degree in Regulatory Affairs, Clinical Research Management, or related field required
• Master's or an advanced Degree preferred
• Training (appropriate to anticipated duties study-specific training, or other as applicable to assigned responsibilities).
• Familiarity with sponsor-led Clinical Research preferred

Benefits & Perks:

• Health, Dental, Vision (with HSA plans and employer contribution)
• 3 weeks PTO
• 5 days Sick Time
• 7 Company holidays + 2 Half-days
• 401K with 6% company match
• Short & Long Term Disability
• Educational Assistance
• Shared company vehicles for required travel

Our company requires COVID-19 vaccinations for all current and future employees. Exemptions can be requested for those with a reasonable health or a religious/sincerely-held belief accommodation.

EEO statement

It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.

Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.