Senior Manager, Regulatory Affairs Avanir Pharmaceuticals

POSITION SUMMARY
The Regulatory Affairs team supports Avanir throughout the product development and commercial life cycle by interacting with regulatory agencies, facilitating regulatory activities, preparing regulatory documentation and coordinating company-wide interactions. This is done by ensuring that Avanirs submissions are correct and timely, by providing appropriate regulatory knowledge and support and ensuring that Avanir operates within governmental regulations.

The incumbent will be responsible for planning and coordinating all regulatory submissions and activities from pre-submission to approval of product/application. He/she will be responsible for assessing regulatory authorities data requirements and be responsible for authoring certain portions and oversee editing and publishing of final submissions to meet these requirements.

This position will provide regulatory and technical expertise into the Company's development plans of its product candidates.

ESSENTIAL JOB FUNCTIONS

Represents the regulatory interest of the Company by meeting with regulatory agencies
Provides regulatory advice internally to Avanir to ensure compliance with FDA regulations
Effectively communicates and implements regulatory strategy
with the appropriate departments and/or employees.
Works to minimize regulatory issues and helps prevent unnecessary
regulatory delays
Will train staff in the preparation of documentation for regulatory review in technical areas in cGMPs, and performs regular evaluations
Participate as a primary regulatory reviewer for Avanir's
promotional review committee (PRC)
Write and submit NDA submissions (initial, amendments, supplements, annual reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA, DEA, and state requirements, including Establishment and Drug Listing with FDA; other submissions as required.
Serve as a regulatory subject matter expert to guide Avanir on regulatory related issues, including for INDs, NDAs throughout the product life cycle;

QUALIFICATIONS
5+ years of regulatory experience in the pharmaceutical / biotechnology industry
Must have direct hands on experience preparing and filing IND, NDA submissions annual reports, SNDAs etc.
Experience with multiple aspects of the process development, analytical characterization, process scale-up, and/or regulatory registration of drug products
Comprehensive understanding of regulatory requirements for the drug development process and manufacturing
Understanding of good clinical/laboratory or manufacturing practices, regulatory compliance and statistical reporting.
understanding of scientific methods and the ability to interpret and communicate scientific data to the FDA.
Experience with post marketing regulatory issues, safety surveillance
Must have excellent computer, written and verbal communication skills.
Must be able to effectively collaborate with peers and comfortable working in a matrixed team
Must be solutions oriented and pragmatic
Excellent project management skills is a must

EDUCATION
Bachelor's degree in Business Management, Life Sciences, or related field.

Location:	101 Enterprise Suite 300 Aliso Viejo, CA 92656 United States