Program Development Analyst (Regulatory Affairs Associate)

Job Title: Program Development Analyst (Regulatory Affairs Associate)

Job Description

The Program Development Analyst will play a crucial role in facilitating communication and ensuring compliance within regulatory affairs. This position involves working closely with various stakeholders, including investigators, network staff, industry sponsors, and regulatory bodies, to streamline protocol approvals and maintain comprehensive regulatory documentation.

Responsibilities

• Communicate effectively with staff, investigators, industry sponsors, and regulatory bodies.
• Coordinate the process of protocol approvals and facilitate submissions to the Scientific Review Board (SRB) and Institutional Review Board (IRB).
• Verify SRB and Contracting, Utilization, Regulatory, and Budgeting (CURB) approvals for new protocol and amendment submissions.
• Prepare and submit necessary documents to the IRB and obtain approvals.
• Assist Principal Investigators in preparing IRB applications and informed consent forms.
• Act as a liaison with local IRBs and national regulatory bodies to streamline protocol approvals.
• Manage protocol amendment approval processes and update regulatory binders.
• Develop and utilize a tracking system to ensure annual IRB approvals for trials.
• Collaborate with relevant staff to update study progress reports and submit annual reviews.
• Assist in preparing study closure reports and coordinate the updating of regulatory files.
• Collect and track all necessary regulatory documentation from participating investigators.
• Serve as a liaison for communication regarding regulatory matters between the organization and sponsors.
• Ensure completion of required training programs for investigators and maintain a master file of certifications.
• Review quality assurance reports and provide necessary education on regulatory issues.
• Assist with the development and implementation of administrative policies and procedures.
• Ensure compliance with federal and state requirements for clinical research.
• Assist in training and orientation of new regulatory personnel.
• Maintain working knowledge of applicable guidelines and incorporate them into daily work.

Essential Skills

• Experience with regulatory affairs and documentation.
• Proficiency in IRB submission and Investigational New Drug (IND) processes.
• Strong communication skills and ability to liaise with multiple stakeholders.
• Experience in handling regulatory documentation for clinical trials.

Additional Skills & Qualifications

• Bachelor"s degree with years of experience in clinical regulatory affairs.
• Familiarity with DHHS, FDA, OHRP, NIH, GCP, HIPAA, and other relevant guidelines.

Work Environment

The organization is focused on becoming a world leader in cancer research and offers a dynamic and collaborative work environment. With a team of 70 employees, the organization is committed to advancing cancer prevention, detection, and treatment. Employees are encouraged to contribute to groundbreaking research and benefit from opportunities for professional growth and development. The work environment emphasizes compliance with regulatory standards and fosters a culture of continuous learning and improvement.

Job Type & Location

This is a Contract to Hire position based out of New Brunswick, NJ.

Pay and Benefits

The pay range for this position is $35.00 - $40.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on May 29, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.