Associate Director, Regulatory Affairs & Quality

We are looking for an Associate Director, Regulatory Affairs & Quality to join our team!

Are you someone with background in clinical research quality management and knowledge of regulatory compliance? Someone who is able to see the bigger picture and adapt to change easily? If the answers are yes, keep reading!

Responsibilities:

• Lead the Regulatory Affairs function within the Quality & Regulatory functional area and deliver to departmental and organizational quality and regulatory goals.
• Provide leadership across the organization to maintain compliance with all quality and regulatory obligations. Provide regulatory support to the clinical research team, including ensuring all trials are conducted in accordance with ICH GCP and local regulations and that CPC regulatory processes are followed or revised as needed. Accountable for anticipation, preparation and delivery of CPC deliverables to the FDA and other regulatory bodies Including oversight of vendors delivering ex-US regulatory content.
• Understand, assess and comply with all applicable regulations for ongoing and future clinical trials and relevant CPC policies (POL), standard operating procedures (SOPs) and work instructions (Wis).
• Research, interpret, and communicate to internal team region specific clinical trial regulatory requirements based on trial specifics including development of regulatory compliance plans for any study and staff training.
• Oversee all drug distribution activities for trials including labeling, importation, depot management, distribution to sites/subjects, and certification of destruction at end of study to time and budget.
• Manage coordination and submission of country-level study applications, regulatory response, updates, and ongoing annual reporting to applicable regulatory authorities outside the United States.
• Accountable for compliance with clinicaltrials.gov and CTIS posting requirements
• Accountable for CPC’s compliance with study-level regulatory requirements including documentation to central Institutional Review Boards (IRB) or Ethics Committees (EC), protocols for initial approval, protocol amendments, memoranda, and continuing reviews in North America.
• Ensure that CPC remains in compliance with all relevant regulatory requirements within the US and ex-US, including development of compliance plans for all ongoing studies, including requirements that are unique to sponsors of clinical studies.
• Ensure that study level templates are compliant with regulatory-required elements.
• Oversee the review and approval of site-level regulatory documents, including those required to approve release of investigational product.
• Lead preparation and submission of periodic reports to health authorities when CPC is the sponsor or when delegated by the sponsor.
• Manage compliance of all CPC vendors delivering ex-US regulatory content.
• Oversee development and implementation of regulatory and other assigned clinical trial documents for GCP compliance and report findings to applicable functional area(s) and the Executive Director.
• Serve as a regulatory representative for computerized systems acquisition, implementation, maintenance, and retirement initiatives.
• Work with the Associate Director of Quality and the Director of Operations to evaluate departmental and organizational metrics on regulatory and quality performance.
• Help administer CPC’s regulatory and Quality Management Systems (QMS), programs and activities, including identification of unmet needs, development and implementation of any new systems.
• Help identify process gaps and revise POLs, SOPs and WIs to ensure compliance with applicable regulations and guidelines.
• Help monitor the development, periodic review, revision, approval, version control, and historical archival of controlled documents within the QMS.
• Assist with internal audits to ensure that CPC is compliant with all applicable local, federal and international regulations, guidelines and standards.
• Assist with external audits for clinical sites, vendors, subcontractors, partners, third-party CROs and others as appropriate.
• Help prepare and implement compliance specific training programs and assist with the development of cross-departmental training programs.
• Manage, mentor and train and cross-train direct reports, if applicable, including setting clear job expectations, and ensuring they receive appropriate coaching as needed.
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree preferred, but equivalent experience will be considered.
• Minimum of 5 years of experience in regulatory functions in a clinical research setting required, preferably with significant experience in Quality Compliance and Assurance. Knowledge of and experience with applicable regulatory requirements compliance (e.g. ICH, GCP and FDA) for conducting clinical trials.
• Proficiency in Microsoft Office, particularly Word and Excel.
• Supervisory experience required.
• Ability to lead a team and manage direct reports.
• Excellent organizational skills as well as oral and written communication skills.
• Good problem-solving skills and strong attention to detail.
• Ability to prioritize and independently manage multiple projects and tasks.
• Ability and willingness to travel up to 10% of the time. 

Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $131,000 – $165,000 annually

Deadline to Apply: July 1, 2025

About CPC:

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

CPC offers:

·       Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)

·       Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)

·       11 paid holidays

·       15 - 25 vacation days based on years of service

·       Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 

·       In-suite exercise and relaxation room

·       Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)

·       Flexible and remote work schedules

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.  

Compensation$131,000 - $165,000