Associate Director of Regulatory in Irvine, CA at Apex Life Sciences

Date Posted: 2/10/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    2/10/2018
  • Job ID:
    759469

Job Description


Pharmaceutical Company is seeking an Associate Director of Regulatory Submissions to join their team!

Responsibilities:
•    Formulate regulatory strategies to reduce risks associated with clinical, nonclinical and CMC sections of marketing applications and work with respective teams to implement them.
•    Regulatory submissions including CMC, nonclinical and clinical documents.
•    Critically review all data and documents to ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements.
•    Serve as a FDA liaison for submissions. 
•    Coordinates phone calls, schedule and facilitate meetings, and correspondence with the agency as appropriate. 
•    All tasks associated to regulatory submissions to support regulatory applications. 
•    Lead department initiatives to improve standards and systems internally. 
•    Prepare and deliver effective presentations for external and internal audiences.
•    Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
•    Represent RA at project team meetings and coordinates workflow between departments as well as CROs.
•    Review and approve investigator site regulatory documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to FDA requirements
•    Other related duties as assigned

Requirements:
•    BS degree in any scientific discipline.
•    10+ years of experience in regulatory from the Pharmaceutical Industry. 
•    Experience with CMC regulatory requirements 
•    Solid understanding of formulation development and drug product analytical characterization
•    Excellent verbal and written communication skills.
•    Medical and technical aptitude and advanced technical writing skills.
 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.