Regulatory Associate in Gaithersburg, MD at Apex Life Sciences

Date Posted: 11/3/2018

Job Snapshot

  • Employee Type:
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

We are searching for a Regulatory Associate to join a leading pharmaceutical company focused on therapies for rare disease in Gaithersburg, MD!  (CMC, Regulatory, FDA Submission)


The Regulatory Associate will provide regulatory (CMC, clinical, non-clinical) support for commercial products and R&D projects. The individual will contribute to regulatory submissions and regulatory/scientific strategy relevant to the assigned projects and serve on project teams.


  • Provide regulatory guidance and support to ongoing and new projects
  • Prepare submission packages for appropriate regulatory agencies
  • Provide technical and scientific support for ongoing manufacturing operations at contract manufacturing organizations (CMOs)
  • Communicate with internal and external stakeholders in order to maintain regulatory compliance
  • Author regulatory submissions relevant to the assigned projects
  • Review and contribute to regulatory documents (e.g., method development/validation reports, technology transfer reports, stability protocols, product specifications, comparability protocols and reports)
  • Collect and review regulatory documentation required for authoring IND, NDA, and BLA sections, and annual reports
  • Contribute to nonclinical, clinical, biomarker development, and manufacturing development studies


  • Bachelors or Masters degree in Biology, Biochemistry, or Chemistry
  • 1-5 years working in a regulatory affairs department
  • Experience contributing to CMC and other regulatory submissions
  • Experience with electronic DMS and eCTD submissions
  • Knowledge of FDA Regulations and FDA/ICH Guidances.
  • Strong verbal and written communication skills.


  • Strong data analytical skills and experience with statistical software
  • Strong background in chemistry

For immediate consideration, please email your resume to


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 844-463-6178.