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Job: Senior Manager/Director Regulatory Affairs (Respiratory), Aurobindo Pharma USA, Durham, NC


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General Information

(3626719)

Job title: Senior Manager/Director Regulatory Affairs (Respiratory)
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Job location: Durham, NC  27703 United States
Requisition code: 2929 Weck Drive
Date posted: 08/21/2017
Compensation: Competitive
Job category:Research and Development
Employment type:Full time
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Job Description


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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. This position manages all employees of the department and is responsible for the performance management and hiring of the employees within that department.

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 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
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Job Requirements


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

Experience:
? 8 + years total, and in MDI aerosol generics – 5+ years

? Must have MDI generics filing experience (not Nasal or other dosage forms); interacting with the FDA, developing Regulatory strategy

? Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions
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