Senior Manager, Regulatory Affairs Avanir Pharmaceuticals
THIS JOB HAS EXPIRED POSITION DETAILS
The Regulatory Affairs team supports Avanir in its ability to market drugs throughout the development life cycle by interacting with Regulatory Agencies, by facilitating regulatory activities, by 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 position will be responsible for working closely with the Senior Director of RA, 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.
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 Avanirs 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;
Bachelors degree in Business Management, Life Sciences, or related field.
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
||101 Enterprise |
Aliso Viejo, CA 92656
THIS JOB HAS EXPIRED