Regulatory Affairs Specialist II


Rockville, MD 20847



This position is responsible for coordinating and preparing document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Will support senior Regulatory Affairs / CMC Regulatory Affairs staff working with development partner companies by facilitating regulatory activities to support company-sponsored clinical trials including responding to document requests. In addition, this role will be responsible for providing regulatory support for internal audits and inspections and maintaining departmental files and databases.

Responsibilities and Job Duties

  • Identifies the appropriate process to follow based on the scope of the submission and then compiles all materials required in submissions.
  • Coordinates and prepares regulatory documents needed for annual reports, new investigators, SUSARs, internal audits and inspections, and other related requests. Ensures documents and all materials are complete and meet all submission requirements and timelines.
  • Reviews site regulatory packages for clinical trial sites participating in company-sponsored clinical trials, as per company SOPs and Work Practices. Raises concerns and issues to senior RA team members.
  • Updates departmental and company databases, e.g., master commitment tracker, 1572 reports, Trial Master Files. Organize and maintain hard copy and electronic department files and monitors and improves tracking/control systems.
  • Uploads Health Authority communications into electronic document management system.
  • When appropriate, recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.
  • Assists with regulatory intelligence activities and keeps abreast of regulatory procedures and changes, shares new information with team and trains stakeholders if necessary.

Minimum Qualifications

Education & Other Credentials:

BA/BS or equivalent in a related field of study


Two years of experience in a similar role in Regulatory Affairs in the pharmaceutical industry

Knowledge, Skills and Abilities

  • Ability to work in a scientific and technical-oriented environment
  • Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
  • Must possess ability to handle multiple priorities in a fast-paced environment
  • Must possess excellent written and verbal communications skills
  • Must also be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact (e.g. ability to be on call for any critical submission-related issues)

Preferred Qualifications

  • A science or technical degree
  • Expertise in MS Office
  • Experience with EDM systems
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