Regulatory Affairs Manager in New Providence, NJ at Apex Life Sciences

Date Posted: 7/19/2018

Job Snapshot

Job Description


Regulatory Affairs Manager (FDA, Pharmaceutical, R&D)

Job Summary:

  • Compile, review, submit, and manage eCTD submissions to the FDA. 
  • Assist in developing regulatory strategy for existing and pipeline products.
  • Maintain GDUFA Self-Identification, User Fee and Establishment Registration processes.
  • Demonstrate solid teamwork with RA team members; meet aggressive deadlines to ensure that Regulatory Agency receive timely and quality submissions to support Company’s goals and objectives.

Job Responsibilities:

  • Review and manage submitting eCTD submissions for generic and new drug development projects and marketed products to ensure timely submissions to the FDA (Original Applications, Amendments, Supplements, and Annual Reports). 
  • Assist RA in developing regulatory strategy for upcoming projects
  • Manage submitting Drug Listing and SPL/PLR submissions
  • Manage electronic submissions to FDA in eCTD format.
  • Manage and review change control documents, batch records, and other technical documents
  • Coordinate and work with Regulatory/R&D colleagues for the preparation regulatory submissions
  • Maintain and improve working knowledge of current/pending regulations and guidances for generic drugs and new drugs to ensure compliance with Regulatory Agency requirements.
  • Manage the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate consistency.
  • Manage and review of labeling and promotional materials for submission to the Regulatory Agency.
  • Maintain GDUFA Self-Identification status and update annually
  • Manage annual GDUFA User Fee payments
  • Manage and maintain Facility Establishment Registration status
  • Maintain and renew other permits and licenses
  • Assist in authoring and finalizing departmental SOPs
  • Perform all other duties as assigned, or as business needs require

Qualification and Requirements:

  • Bachelor’s degree in chemistry, biology or other related scientific discipline required.
  • At least 5-7 years in the pharmaceutical industry with at least 5-6 years of Regulatory experience supporting US FDA pharmaceutical products
  • Excellent understanding of regulatory requirements for ANDAs and 505b(2) applications  
  • Proficiency in eCTD Publishing Software is a must
  • Previous R&D (analytical or formulation) experience is a plus
  • 505b(2) experience is a plus
  • Good knowledge of FDA guidelines, ICH and related guidelines
  • Demonstrates a basic understanding of pharmaceutical drug development.
  • Proficiency in Microsoft office and XML programs
  • Ability to establish and maintain good working relationships
  • Ability to travel domestically: 20% of the time

FOR IMMEDIATE CONSIDERATION please email your resume to woodbridgels@apexlifesciences.com or call 732-636-1497

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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.

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.