Regulatory Affairs & Compliance Lead, PET Radiopharma

Massachusetts General Hospital; Boston (MA); On-site; USD 99,000 - 142,000; Full time

Job summary

The MGH PET Production Facility at Mass General Brigham, located at 60 Blossom Street, seeks a Regulatory Affairs & Compliance Manager to lead cGMP documentation, regulatory submissions, and QA programs for radiopharmaceuticals. The role ensures inspection readiness and adherence to FDA, MA DPH, MA Board of Pharmacy guidelines.

The ideal candidate has 3–5 years in pharmaceutical manufacturing, 2–3 years supervisory experience, and a Bachelor’s degree in Regulatory Affairs or Pharmaceutical

Qualifications

• Bachelor's degree required.
• 3 - 5 years of direct experience in a pharmaceutical manufacturing field.
• 2-3 years supervisory experience.
• Preferred: Certification in quality management or other cGMP certification.

Responsibilities

• Authors and reviews of standard operating procedures, technical reports, and other cGMP documents
• Educates staff and organizational members and project participants on quality improvement methodologies and tools
• Provides leadership and hands‑on participation in projects to develop quality improvement skills
• Develops a quality improvement culture with staff and leaders to support organizational development
• Maintains an updated library of FDA regulations and guidance documents
• Performs annual product quality review for each radiopharmaceutical
• OOS investigation coordination
• Change control management
• CAPA management and verification of efficacy
• Vendor complaint handling
• Assists with IND submissions, annual reports, amendments, etc.
• Maintain inspectional readiness
• Tracking and trending data related to investigations, environmental monitoring, production
• Record keeping maintaining compliance with the following regulatory authorities: Massachusetts Department of Public Health, Massachusetts Board of Pharmacy, Food and Drug Administration, Radiation Safety Department, Hospital Policies
• Collaboration with PET Production/Cyclotron staff in the performance of quality investigations
• Maintaining a positive working relationship with vendors and hospital service providers (e.g. Buildings and Grounds)
• Documentation of facility repairs
• Calibrated equipment inventory management
• Equipment IQ/OQ documentation review
• Documentation management per institution document control policy
• Leads improvements to quality management system
• Serves as liaison between industry partners and facility for collaboration work
• Oversees personnel training program and documentation

Skills

Regulatory Affairs

Education

Bachelor's degree in Regulatory Affairs/Pharmaceutical Science

Job description

The MGH PET Production Facility at Mass General Brigham, located at 60 Blossom Street, seeks a Regulatory Affairs & Compliance Manager to lead cGMP documentation, regulatory submissions, and QA programs for radiopharmaceuticals. The role ensures inspection readiness and adherence to FDA, MA DPH, MA Board of Pharmacy guidelines.

The ideal candidate has 3–5 years in pharmaceutical manufacturing, 2–3 years supervisory experience, and a Bachelor’s degree in Regulatory Affairs or Pharmaceutical