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Sr. Associate, Regulatory Operations

Cambridge, Massachusetts

Post Date: 07/12/2017 Job ID: 1566 Job Category: Clinical: Regulatory

Reporting to the Associate Director, Regulatory Operations, the Senior Associate of Regulatory Operations will assist with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document management. In addition to assigned projects, responsibilities include evaluation of current processes and systems with regard to industry best practices, available resources, and evolving U.S. and international regulations and guidelines. Then, based on such evaluations, propose changes targeting greater efficiency and continued compliance. This position will also be responsible for participating in day-to-day Regulatory Operation activities in support of the company’ s goals.

Job  Responsibilities:
  • Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities;
  • Provide detailed project timeline information to supervisor to support resource forecasting;
  • Coordinate and participate in the production of electronic regulatory submissions and, as required, paper submissions;
  • Develop proposals for system and process development or modification to support greater efficiency and continued regulatory compliance;
  • Assist with the development and implementation of processes related to submission standards, working practices, and quality controls;
  • Support and conduct cross functional training on submission standards and procedures as required;
  • Support compliance with worldwide submission regulations and guidelines.


Qualifications/  Requirements:
  • Demonstrated skills managing project timelines and organizing supporting resources;
  • Understanding of U.S. submission requirements; Understanding of international requirements a plus;
  • 4 years of pharmaceutical industry experience;
  • 4 years of experience compiling electronic submissions;
  • 4 years of experience in electronic document publishing;
  • Experience compiling IND, NDA/BLA, and CTD submissions;
  • Understanding of eCTD submission requirements;
  • Proficient with Microsoft Office products and Adobe Acrobat;
  • Advanced skills with submission publishing software;
  • Extensive experience using electronic document management systems;
  • Familiarity with system validation practices;
  • Bachelor’ s degree or equivalent experience;

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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