Regulatory Specialist

ResponsibilitiesPrepare, distribute, and track regulatory submissions including INDs, BLAs, NDAs, and IDEs.Ensure compliance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.Prepare scientific and regulatory documents for submission to the FDA and other Health Authorities.Attend scientific meetings and review literature to stay current with new developments in infectious diseases and therapeutic clinical research.Perform literature searches and attend meetings to support regulatory document preparation, regulatory intelligence, and regulatory strategy.Essential SkillsExperience in regulatory affairs, clinical research, and preparing regulatory documents.Knowledge of regulatory documents, GCP, clinical trials, vaccine development, infectious diseases, drug development, IRB, IND, and BLA.Excellent oral and written communication skills.Detail-oriented and able to multi-task and prioritize effectively.Ability to analyze medical research data and review experimental protocols.Strong working knowledge of Microsoft Office.Additional Skills & QualificationsExperience with SharePoint is a plus.Professional or educational background in a scientific field, clinical trials, regulatory affairs, or healthcare.Familiarity with GCP and/or experience working in an FDA-regulated environment is desirable.General knowledge of the drug/vaccine development process or clinical trials is a plus.Experience in publishing regulatory submissions using electronic publishing software and preparing documents compliant with electronic submission standards.Work Environment

Full-time in office, 8:00 AM to 4:30/5:00 PM depending on lunch break duration.

Pay and Benefits

The pay range for this position is $75000.00 - $85000.00/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 onsite position in Bethesda,MD.

Application Deadline

This position is anticipated to close on Mar 7, 2025.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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.