Remote Research Regulatory Specialist II

Actalent; United States; Remote; USD 77.000 - 79.000; Vollzeit

Benefits dieser Stelle

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Time Off from Day One

403(b) Retirement Plan

Career Development

Well-being Resources

Zusammenfassung

Actalent seeks a Research Regulatory Specialist II to provide advanced regulatory support for clinical research teams. You will handle IND/IDE and biologics submissions, coordinate across multiple sites, and ensure regulatory documentation meets federal and institutional standards.

The role emphasizes data gathering, regulatory filing preparation, and collaboration with investigators, sponsors, and offices to maintain compliance and timely submissions.

Qualifikationen

• Experience providing regulatory support for clinical research and regulatory filings.
• Strong understanding of FDA IND/IDE and biologics applications.
• ICH/GCP, AAHRPP, and applicable regulations governing human subjects research.
• Experience with IRB submissions, amendments, continuing reviews, and informed consent.

Aufgaben

• Assist FDA IND/IDE and biologics submissions for institution-held applications.
• Gather and assemble data for regulatory filings with FDA and authorities.
• Prepare FDA reports for ongoing IND/IDE applications.
• Coordinate regulatory processes for multi-site studies across sites.
• Support onboarding of new Regulatory Specialists.
• Prepare protocols, amendments, continuing reviews, and device manuals for submissions.

Kenntnisse

Regulatory support experience

FDA IND/IDE knowledge

ICH/GCP familiarity

IRB processes

Data compilation for filings

eRegulatory systems

Regulatory QA/compliance

Oncology regulatory experience

Ausbildung

Bachelors in healthcare/biological sciences

Associate degree + 3+ years healthcare/science

5+ years in healthcare/scientific setting w/ regulatory focus

Tools

eRegulatory systems

Jobbeschreibung

Actalent seeks a Research Regulatory Specialist II to provide advanced regulatory support for clinical research teams. You will handle IND/IDE and biologics submissions, coordinate across multiple sites, and ensure regulatory documentation meets federal and institutional standards.

The role emphasizes data gathering, regulatory filing preparation, and collaboration with investigators, sponsors, and offices to maintain compliance and timely submissions.