The Clinical Product Regulatory Specialist is responsible for management of regulatory and investigational product (IP/IMP) activities to support CPC’s clinical trials. This includes managing and developing (where necessary) internal processes as well as managing external service providers [Contract Manufacturing Organizations (CMOs)] used for product supply, including labeling and production, and distribution and shipping of IP in compliance with applicable regulations and coordination of supporting regulatory documents.

Regulatory Responsibilities:

• Ensure that the organization follows the requirements outlined by the Food and Drug Administration (FDA) and other relevant regulatory agencies.
  • Maintain relationships with the regulatory agencies that oversee their industries including ex-U.S.
  • Serve as a liaison between regulatory agencies and other related organizations.
  • Ensure that all CPC’s documentation remains accurate and up-to-date.
  • Prepare regulatory document templates for distribution to clinical sites.
  • Provide regulatory support to the Operations teams, including ensuring all trials are conducted in accordance with all relevant regulations.
  • Report adverse events to regulatory authorities including ex-U.S., as needed.
  • Review and approve site-level regulatory documents.
• Submit to and maintain public trial database postings, such as clinicaltrials.gov, EudraCT, etc.
• Submit study-level documentation to central Institutional Review Boards (IRB) or Ethics Committees (EC).
• Prepare and submit country-level study applications, updates, and ongoing annual reporting to the US Food & Drug Administration (FDA).

• Lead preparation and submission of periodic reports to health authorities.

Supply Management Responsibilities:

• Oversee internal requirements and liaise with external parties in the coordination of IP lifecycle activities for trials including importation, depot management, labeling, distribution to sites/subjects, and certification of destruction at end of study.

• Establish and document supply chain, supply planning/forecasting to ensure alignment with study activity and timelines.
• Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid supply issues.
• Manage, reconcile, maintain, and report IP inventory to assure proper distribution of IP to study sites.
• Develop excellent working relationships with Quality Assurance (QA) for timely review and approval of batch records for packaging and labeling of IP.

• Follow up on reported Temperature Excursions and/or Product Complaints from sites/depots.

• Ensure expiry extensions are provided to depot/sites as needed to support continued use.
• Manage return and destruction of IP, with proper documentation of all steps.
• Ensure appropriate documentation of IP supply activities is filed in the Trial Master File.
• Assist the Legal team with selection and contracting of Interactive Response Technology (IRT) and drug supply providers.
Facilitate the design, review, implementation of the IRT.

Qualifications:

• Bachelor’s degree or higher in health or life sciences, required.
• Minimum of 5 years’ experience in the pharmaceutical/biotechnology industry performing international clinical trial regulatory management in drug development required, with at least 3 years of management experience in regulatory matters.
  • 2 years of product supply logistics/management preferred
• Experience interpreting clinical trial protocols.
• Experience interacting with drug depots, management or importation companies in the context of clinical trials.
• Understanding of safety reporting regulations and guidelines.
• Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives.
• Experience with IRT System design, implementation, user testing and monitoring.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook, etc.) and Electronic Data Capture systems.
• Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication, including experience with conflict resolution and team alignment.
• Great attention to detail.
• Ability to mentor as well as work with others in a manner that promotes group effort and achievement.

Targeted Compensation: $90,000 - $102,000 annually

Deadline to Apply: April 1, 2024

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

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 30 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.