Senior Regulatory Manager: Clinical Trials, Onsite Baltimore

Pharmaron Beijing Co. Ltd.; Baltimore (MD); Presencial; USD 80.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Generous PTO & Holidays

Employer-funded HSA contributions

Descripción de la vacante

Pharmaron Beijing Co. Ltd. seeks an experienced Regulatory Manager to lead regulatory activities for clinical trials in a fast-paced CRO environment. You will oversee IRB submissions, TMF maintenance, and team leadership to ensure lifecycle regulatory compliance.

The role requires deep expertise in regulatory submissions, document management, and cross-functional collaboration to support Phase I–IV studies onsite in Baltimore, MD.

Formación

• Bachelor's degree or equivalent in life sciences or related field.
• 5–10 years of clinical research regulatory experience.
• 5–10 years of hands-on experience managing IRB submissions and approvals.
• 5–10 years of experience managing essential documents for clinical trials.
• Strong working knowledge of ICH-GCP Guidelines, FDA regulations, 21 CFR Part 50 and 56.

Responsabilidades

• Lead regulatory activities from study startup through closeout.
• Mentor and develop Regulatory team members.
• Maintain regulatory binders and eTMF; ensure inspection readiness.
• Serve as primary liaison with Sponsors, IRBs, Clinical Operations, and Quality teams.
• Oversee study startup regulatory documentation and sponsor readiness activities.

Conocimientos

Regulatory leadership

IRB submissions

Clinical trials

Educación

Bachelor's degree in life sciences

Herramientas

Veeva Vault TMF

Florence eTMF

Descripción del empleo

Pharmaron Beijing Co. Ltd. seeks an experienced Regulatory Manager to lead regulatory activities for clinical trials in a fast-paced CRO environment. You will oversee IRB submissions, TMF maintenance, and team leadership to ensure lifecycle regulatory compliance.

The role requires deep expertise in regulatory submissions, document management, and cross-functional collaboration to support Phase I–IV studies onsite in Baltimore, MD.