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Regulatory Operations Associate

Cambridge, MA

Posted: 11/19/2019 Employment Type: Contract Job Category: Clinical: Regulatory Job Number: 2449

Job Description


Reporting to the Senior Manager, Regulatory Operations, the 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.

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
  • Demonstrated skills managing project timelines and organizing supporting resources

Requirements / Qualifications:
  • Bachelor’ s degree or equivalent experience
  • Understanding of U.S. submission requirements; understanding of international requirements preferred
  • 1 year of pharmaceutical industry experience
  • 1 year of experience compiling electronic submissions
  • 1 year of experience 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
  • Superb organizational skills and attention to detail
  • Demonstrated ability to manage priorities and work under tight timelines
  • 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

Meet Your Recruiter

Kelley Cole
Clinical Recruiter

Kelley brings 5 years of experience in full life-cycle recruitment and talent acquisition management, along with a strong client services background, to her role as Clinical Recruiter for The Steely Group. A desire to make a difference and add positivity to this world are two factors that influenced Kelley’s decision to become a recruiter. “Connecting a candidate with a better opportunity that could have a huge impact on them and their family is very fulfilling,” she says.

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