Regulatory Specialist

Mid Atlantic Retina; Philadelphia (Philadelphia County); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company is seeking a Regulatory Specialist responsible for writing and submitting regulatory documents to FDA and IRB. The role involves managing clinical data, ensuring compliance with regulations, and supporting research efforts across multiple locations. Ideal candidates will have at least 2 years of experience in regulatory affairs and strong knowledge of guidelines.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short & Long Term Disability

Paid Time Off

401(k) & Profit Sharing

Uniform Allowance

Mileage Reimbursement

Bonuses

Qualifications

• Minimum of 2 years of experience in Regulatory Affairs in Research & Development.
• Strong knowledge of applicable regulations is essential.

Responsibilities

• Write and submit regulatory documents to FDA and IRB.
• Manage and maintain regulatory documentation for studies.
• Conduct internal audits for regulatory compliance.

Skills

Knowledge of GCP's

Knowledge of ICH guidance documents

Job description

This position is eligible for Mid Atlantic Retina's $1,000 Hiring Incentive! The hired candidate will receive $500 after successful completion of 90 days of employment and $500 after successful completion of 1 year of employment! Available to new hires only- not available to agency hires, internal transfers, or re-hires.

Job Description

The primary responsibility of the Regulatory Specialist is to write, and complete submission of regulatory documents to FDA and IRB and assist administratively in all areas of research. The Regulatory Specialist is responsible for collecting, recording, and managing all clinical data.

Essential Functions

1. Study start-up documentation (1572s, financial disclosure forms, site staff signature logs, informed consent modification for local IRB).
2. Regulatory submissions adhering to submission schedule and IRB guidelines. Submissions include protocol amendments, protocol deviations/violations, on-site and off-site SAE reporting, continuing Reviews, Supplementary materials (advertising materials) for all locations.
3. Maintenance of regulatory documentation for all studies and all doctors (correspondence, protocols, training requirements, training logs, curricula vitaes, current medical licenses).
4. Manage and maintain regulatory database.
5. Work closely with study monitors to ensure completeness and accuracy of regulatory documents. Site visit follow-up correspondence filed after action items completed.
6. Maintain current records on relevant training: Clinical Research Coordinator Training, IRB Training for Human Subjects in Research, HIPAA Training.
7. Schedule physician attendance and availability for IRB meetings.
8. Follow up on action items from IRB.
9. Add, maintain and provide study summaries to Clinicaltrials.gov.
10. Manage MAR research website (creation, additions and updates).
11. Managing and maintaining trial master files for all studies
12. Conduct internal regulatory database and trial master file audits for industry and investigator sponsored studies.
13. Back-up clinical research coordinators and assist with data entry and/or completion of case report forms (CRFs). Resolution of data discrepancies.
14. Create and maintain standard operating procedures (SOP) for research department.
15. Identify and communicate regulatory requirements and obstacles with the research manager, director and principal investigators.
16. Determine when study files can be shipped for offsite storage and destruction dates.
17. Update all physicians CV research study list (including start and end dates).
18. Attend monthly research meetings.

Travel to other Mid Atlantic Retina locations is required for this position

Required Education and Experience

• Minimum of 2 year of experience in Regulatory Affairs in Research & Development
• Candidate must have strong knowledge of regulations including GCP's & ICH guidance documents.

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short & Long Term Disability
• Paid Time Off
• 401(k) & Profit Sharing
• Uniform Allowance
• Mileage Reimbursement
• Bonuses