Avanir Pharmaceuticals

VP, Regulatory Affairs & Quality Assurance

Location
Aliso Viejo, CA, United States
Posted
Jan 13, 2021
Ref
R2561
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Vice President of Regulatory Affairs is responsible for providing regulatory leadership and for the planning and oversight of all regulatory submissions from pre-submission to approval of product(s)/application(s). Responsible for addressing data requirements to regulatory authorities. This position will provide the regulatory and technical expertise into the Company's development plans of its product candidates. Prepares for and expedites early and effective approval of pharmaceutical new products in accordance with regulatory strategy. They will work cross-functionally with R&D, Quality, supply chain, compliance, legal, operations, marketing and other departments.

Essential Job Functions:
  • Represents the regulatory interest of the Company by meeting with regulatory agencies
  • Provides expert regulatory advice internally to Senior Management and Board of directors when needed to ensure compliance with FDA regulations.
  • Effectively communicates and implements determined 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, and performs regular evaluation
  • Ensure compliance of Company SOPs, protocols, and specifications in order to codify procedures to be used as a reference among Company employees and contractors
  • Perform record review to assure quality submission of regulatory documents.


This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Education/ Qualifications:
  • BA/BS Required, MBA is a plus or equivalent experience
  • 12+ years of regulatory experience in the pharmaceutical / biotechnology industry
  • Must have direct hands-on experience preparing and filing IND, NDA & BLA submissions and representing Company to FDA and other regulatory agencies
  • Extensive knowledge of US and global regulatory requirements · Must be knowledgeable in industry trends for report and dossier preparation (e.g., IND/CTA/NDA/MAA, including electronic document submissions (i.e., eCTD).
  • Must have thorough understanding of good clinical/laboratory or manufacturing practices, regulatory compliance and statistical reporting.
  • Must possess the understanding of scientific methods and the ability to interpret and communicate scientific data to the FDA.
  • Must have excellent PC, written and verbal communication skills.
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution · Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Strong leadership skills, team player, problem solver, strategic thinker and excellent collaborator.


Physical Requirements:

This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.

Work Environment:

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.

EEO Statement:

As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.

Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.