Sign upLog in

Sr. Manager-Director, Regulatory Affairs (Respiratory)

Integrated Resources, Inc

Raleigh, North Carolina

Apply
JOB DETAILS
JOB TYPE
Full-time
SKILLS
Abbreviated New Drug Application, Aerosols, Analysis Skills, Biotech and Pharmaceutical, Chemistry, Clinical Research, Conferences, Dosage Forms, FDA (Food and Drug Administration), FDA Requirements, Information Technology & Information Systems, Interpersonal Skills, Metered Dose Inhalers, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Regulations, Regulatory Submissions, Rehabilitation Nursing, Research & Development (R&D), Respiratory Medicine, Strategic Planning, Time Management
LOCATION
Raleigh, North Carolina
POSTED
3 days ago
Sr. Manager-Director, Regulatory Affairs (Respiratory)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.Job DescriptionREPORTING RELATIONSHIPSWill report to President, R&D, USA. May be responsible for managing up to 2 RA staff including U.S. and India.DUTIES & ESSENTIAL JOB FUNCTIONSThis position is responsible for all Regulatory Strategy and Filing aspects of MDI aerosols development, including CMC and possibly, Clinical strategy.OTHER FUNCTIONS AND RESPONSIBILITIESKeep abreast of new Regulatory and Scientific developments in the Respiratory area.Additionally take on Derma & Transdermal RA responsibilities.QUALIFICATIONSRegulatory experience supporting Generic Respiratory MDI aerosols development is a must!Good scientific/technical understanding of the MDI aerosols spaceExcellent written and spoken communication skillsExcellent interpersonal skillsAttention to details, quality and follow-throughProject management and excellent time-management and organization skillsExcellent analytical skills and problem solving abilityDUTIES & ESSENTIAL JOB FUNCTIONS40% - Develop and provide Strategic Regulatory guidance/advice to Project Teams30% - Manage all Regulatory aspects of Respiratory ANDA filings20% - FDA interactions via e-mail, tel., mtgs, conferences5% - Provide updates to senior & executive management5% - Recruiting, training, team buildingQualificationsEducation:Master's/PhD – in Chemistry/Pharm. SciencesExperience:Must have MDI generics filing experience (not Nasal or other dosage forms); interacting with the FDA, developing Regulatory strategy8 + years total, and in MDI aerosol generics – 5+ yearsExperience with regulatory agency interactions and preparation of documents for regulatory agency interactions

About the Company

I

Integrated Resources, Inc