Remote FDA Regulatory Expert

Pharmavise Corporation; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Pharmavise Corporation is seeking an experienced regulatory expert for a fully remote role in the United States. You will provide expert guidance on FDA regulations across drugs, biologics, and medical devices, and support submissions from INDs to PMAs.

You will collaborate with cross-functional teams to align regulatory strategy and ensure timely, compliant submissions. Ideal candidates have 5+ years at the FDA, strong communication skills, and a proven record of successful regulatory

Qualifications

• Minimum 5 years at the FDA in regulatory role with drug/biologic/medical device focus.
• Deep knowledge of FDA regulations, guidance documents and processes.
• Proven track record preparing/submitting regulatory applications and participating in FDA meetings.

Responsibilities

• Provide expert regulatory guidance on FDA regulations, policies and submissions.
• Review and interpret FDA guidance to ensure compliant submissions.
• Support INDs, BLAs, NDAs, 510(k)s and PMA submissions with strategy.
• Conduct regulatory assessments and risk analysis for submissions.
• Assist in FDA meetings and act as regulatory representative.
• Monitor FDA trends and inform clients of potential impacts.
• Collaborate with regulatory affairs, clinical, quality, and medical affairs.
• Serve as liaison between clients and regulators, handling inquiries.

Skills

FDA regulatory expertise

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in pharmacy, biology, chemistry

Job description

Pharmavise Corporation is seeking an experienced regulatory expert for a fully remote role in the United States. You will provide expert guidance on FDA regulations across drugs, biologics, and medical devices, and support submissions from INDs to PMAs.

You will collaborate with cross-functional teams to align regulatory strategy and ensure timely, compliant submissions. Ideal candidates have 5+ years at the FDA, strong communication skills, and a proven record of successful regulatory