Regulatory Affairs Specialist

  • Boston, MA, USA
  • Sep 05, 2017

Job Description

Our client, a national consulting firm specializing in the clinical arena, is seeking a Regulatory Affairs Specialist to join their expanding team.

  • Independently manage regulatory projects for multiple biotech and pharma companies, bringing real-world experience and an ability to roll up your sleeves and get the work done
  • Manage regulatory projects and activities focusing on pre-IND guidance, planning global development programs, IND strategies and submissions, special designations and other regulatory submissions and meetings
  • Develop regulatory content and author regulatory documents and submissions
  • Work efficiently and collaboratively with client team members and team members on regulatory strategy and submissions

You will manage multiple regulatory programs for biotech and pharma sponsor companies. These responsibilities may include the full scope of regulatory project management or individual components based on the contracted scope of responsibilities. You will be responsible for developing regulatory strategy and the preparation/review of regulatory submissions including meeting requests, INDs, CTAs, NDAs, MAAs, and ANDAs as well as authoring annual reports, amendments, and supplements. You may also prepare and publish eCTD applications and have direct interactions with the FDA.


Bachelor s degree in life science, business or management (advanced degree is a plus) and 6-10 years of experience in a biotech or pharma setting. Regulatory Affairs Certification (RAC) is a plus. You will need broad experience in regulatory affairs (including clinical trial applications, global marketing authorizations and post approval life cycle management) and the ability to support several projects for different client engagements simultaneously. The ideal candidate will also have experience supporting program level strategic planning activities spanning from pre-IND through marketing approval. You ll be expected to be highly proficient in the MS Word, Excel, Project, and PowerPoint.


  • Excellent oral and written communication and presentation skills
  • Deep understanding of regulatory requirements, guidance and regulatory strategy
  • Client-focused approach to work
  • Action oriented, ready for responsibility, open to learning new skills and willing to help where and when needed
  • Demonstrated ability to work independently with exceptional organization and attention to detail

***For Immediate consideration please email Macy Miller [Click Here to Email Your Resum ]***

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 [Click Here to Email Your Resum ] or 844-###-####.

Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task


Apex Life Sciences