Sr. Manager-Director, Regulatory Affairs (Respiratory)

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

Sr. Manager-Director, Regulatory Affairs (Respiratory)

• Full-time

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

REPORTING RELATIONSHIPS

Will report to the President, R&D, USA. May be responsible for managing up to 2 RA staff including U.S. and India.

DUTIES & ESSENTIAL JOB FUNCTIONS

This position is responsible for all Regulatory Strategy and Filing aspects of MDI aerosols development, including CMC and possibly, Clinical strategy.

OTHER FUNCTIONS AND RESPONSIBILITIES

• Keep abreast of new Regulatory and Scientific developments in the Respiratory area.
• Additionally take on Derma & Transdermal RA responsibilities.

QUALIFICATIONS

• Regulatory experience supporting Generic Respiratory MDI aerosols development is a must!
• Good scientific/technical understanding of the MDI aerosols space
• Excellent written and spoken communication skills
• Excellent interpersonal skills
• Attention to details, quality and follow-through
• Project management and excellent time-management and organization skills
• Excellent analytical skills and problem solving ability

DUTIES & ESSENTIAL JOB FUNCTIONS

40% - Develop and provide Strategic Regulatory guidance/advice to Project Teams

30% - Manage all Regulatory aspects of Respiratory ANDA filings

5% - Provide updates to senior & executive management

5% - Recruiting, training, team building

JOB DESCRIPTION

Education:

Master’s/PhD – in Chemistry/Pharm. Sciences

Experience:

• Must have MDI generics filing experience (not Nasal or other dosage forms); interacting with the FDA, developing Regulatory strategy
• 8 + years total, and in MDI aerosol generics – 5+ years
• Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions