Remote Regulatory Manager — Clinical Submissions

Precision Medicine Group, LLC.; Northern (KY); Hybrid; USD 106,000 - 151,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group, LLC. is seeking a Regulatory Manager to provide regulatory development guidance across the clinical development life cycle and coordinate submissions to regulatory authorities and ethics committees. The role involves leading regional/global efforts, mentoring staff, and shaping regulatory strategy, with travel as needed. The position supports corporate regulatory functions and requires 5+ years in regulatory affairs.

Qualifications

• 5+ years of regulatory affairs experience in pharma or biotech.
• Knowledge of EU and US regulatory submissions including INDs/CTAs.
• Ability to interpret clinical data for regulatory strategy.
• Strong project coordination and cross-functional collaboration.

Responsibilities

• Provide regulatory development guidance across clinical development.
• Coordinate and prepare documents for submission to Regulatory Authorities and Ethics Committees.
• Lead regional or global regulatory projects and manage timelines.
• Mentor Regulatory Affairs staff and contribute to process improvements.
• Support regulatory strategy and timelines for new study opportunities.

Skills

Regulatory affairs experience

Project leadership

Interpersonal skills

Travel readiness

Education

Bachelor's degree or equivalent in scientific/healthcare field

Job description

Precision Medicine Group, LLC. is seeking a Regulatory Manager to provide regulatory development guidance across the clinical development life cycle and coordinate submissions to regulatory authorities and ethics committees. The role involves leading regional/global efforts, mentoring staff, and shaping regulatory strategy, with travel as needed. The position supports corporate regulatory functions and requires 5+ years in regulatory affairs.