Regulatory Affairs Leader - Respiratory & MDI Aerosols

Integrated Resources Inc.; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading staffing firm is seeking a Sr. Manager-Director in Regulatory Affairs for its Respiratory division. The role involves developing regulatory strategies for MDI aerosols and managing regulatory filings, requiring extensive experience in the pharmaceutical industry. Candidates should possess strong communication, analytical, and project management skills, along with a Master's or PhD in a relevant field.

Qualifications

• 8+ years total experience, with 5+ years specifically in MDI aerosol generics.
• Experience with FDA interactions and regulatory strategy development.
• Must have experience in MDI generics filing process.

Responsibilities

• Develop and provide strategic regulatory guidance to project teams.
• Manage regulatory aspects of Respiratory ANDA filings.
• Recruiting, training, and team building responsibilities.

Skills

Regulatory experience

Scientific/technical understanding of MDI aerosols

Excellent communication skills

Interpersonal skills

Attention to detail

Project management

Analytical skills

Problem solving

Education

Master’s or PhD in Chemistry or Pharmaceutical Sciences

Job description

A leading staffing firm is seeking a Sr. Manager-Director in Regulatory Affairs for its Respiratory division. The role involves developing regulatory strategies for MDI aerosols and managing regulatory filings, requiring extensive experience in the pharmaceutical industry. Candidates should possess strong communication, analytical, and project management skills, along with a Master's or PhD in a relevant field.