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Senior Manager, Regulatory Affairs - Generic pMDIs Product Dev
Ref No.: 18-03445
Location: Raleigh, North Carolina
Position Type:Direct Placement
Pay Rate : $ 140,000.00 - 150,000.00 /Year
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, None, Vision Insurance
Senior Manager, Regulatory Affairs - Generic pMDIs Product Dev

Job description
  • Must be legally able to work in the USA without requiring sponsorship.
REPORTING RELATIONSHIPS
Will report to 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 ANDA filing aspects of MDI aerosols development, including CMC and possibly clinical. Will contribute to regulatory strategy. This position manages all employees of the department and is responsible for the performance management and hiring of the employees within that department.

DUTIES & ESSENTIAL JOB FUNCTIONS
-Develop and provide Strategic Regulatory guidance/advice to Project Teams
-Manage all Regulatory aspects of Respiratory ANDA filings
-FDA interactions via e-mail, tel., mtgs, etc.
-Provide updates to senior & executive management

OTHER FUNCTIONS AND RESPONSIBILITIES
  • Keep abreast of new regulatory and scientific developments in the Respiratory area
  • Additionally take on Derma & Transdermal RA responsibilities
  • Perform other duties as assigned

QUALIFICATIONS
  • Regulatory experience supporting Generic Respiratory MDI aerosols development is preferred.
  • 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

REQUIRED:
Education: BS. / Master's Degree / PhD – in Chemistry/Pharm. Sciences


Experience:
  • 4 + years total, and in MDI aerosol generics – 2+ years
  • Preferred to have MDI generics filing experience
  • Experience with US FDA interactions, including preparation of controlled correspondences, ANDA submissions, and other documents for regulatory agency interaction