Sr. Manager-Director, Regulatory Affairs (Respiratory)
Description
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 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
20% - FDA interactions via e-mail, tel., mtgs, conferences
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
Thanks
Warm regards
Avleen Kaur
732-318-6945