Regulatory Operations Specialist

4 weeks ago


Boston, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time
About the Job

Beacon Hill Life Sciences - Boston seeks a highly skilled Regulatory Operations Contractor to support regulatory submission activities, including eCTD production, document publishing, and document management.

Job Summary

This role involves assisting in the development and implementation of systems and procedures used to support regulatory submission activities. The ideal candidate will have strong experience compiling electronic submissions and in electronic document publishing.

Responsibilities
  • Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities;
  • Coordinate and participate in the production of electronic regulatory submissions;
  • Support and conduct cross-functional training on submission standards, procedures, and systems as required;
  • Support compliance with worldwide submission regulations and guidelines;
Requirements
  • Experience compiling electronic submissions and in electronic document publishing;
  • Experience compiling IND, NDA/BLA, and CTD submissions;
  • Understanding of eCTD submission requirements;
  • Excellent communication and interpersonal skills;
  • Demonstrated ability to work well with cross-functional teams;
  • Demonstrated ability to manage priorities and work under tight deadlines;
  • Demonstrated skills managing timelines and organizing supporting resources;
What We Offer

A competitive salary range of $85,000 - $110,000 per year, depending on experience. Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.



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