Regulatory Manager: Global Submissions & Strategy (Remote)

Pfm; United States; Remote; USD 106,000 - 151,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings plan (401k)

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance for clinical trials and ensure timely, compliant submissions to regulatory authorities. You will coordinate documents for CTA/IND submissions and interactions with Regulatory Authorities and Ethics Committees while staying current on regulations.

The role involves leading regional or global projects, mentoring staff, and contributing to corporate Regulatory function.

Qualifications

• Bachelor’s degree or equivalent experience in a scientific/healthcare field.
• Fluent in English.
• 5+ years or more of regulatory affairs experience.
• Knowledge of EU and US regulatory activities, including INDs/CTAs and amendments.

Responsibilities

• Provide regulatory guidance throughout the clinical development life cycle.
• Coordinate and review submissions to Regulatory Authorities and Ethics Committees.
• Lead project teams and coordinate Regulatory Affairs Specialists to meet submission targets.
• Develop regulatory strategies and timelines for new study opportunities.

Skills

Regulatory affairs

Regulatory submissions

Cross-functional collaboration

English fluency

Education

Bachelor's degree or equivalent

Graduate/postgraduate

Tools

MS Office/Office 365

Job description

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance for clinical trials and ensure timely, compliant submissions to regulatory authorities. You will coordinate documents for CTA/IND submissions and interactions with Regulatory Authorities and Ethics Committees while staying current on regulations.

The role involves leading regional or global projects, mentoring staff, and contributing to corporate Regulatory function.