Careers

Regulatory Affairs Specialist II

Position Scope:

The Regulatory Affairs Specialist II is responsible for filing necessary submissions and handling all regulatory authority interactions pertaining to the regulation process for product submissions.  Supports necessary regulatory activities required for product market approval, and post-approval requirements.

Specific Responsibilities:

  • Prepare regulatory documentation packages for review and submission to regulatory agencies or to our commercial partners to achieve departmental and organizational objectives
  • Prepare and archive NDAs, INDs, PMAs, and IDE annual reports and safety reports
  • Assists in developing procedures to ensure regulatory compliance
  • Review preclinical and clinical protocols and reports for compliance with GLP and GCP requirements, respectively
  • Establish and maintain system for tracking changes in documents submitted to agencies or partners
  • Review labeling and engineering changes for compliance with regulatory filings
  • Maintain current knowledge of FDA, ICH, and international guidelines
  • Responsible for other duties and projects as assigned

Job Complexity:

Occasionally directed in several aspects of the work

Supervisory Responsibilities:

None

Required Qualifications:

Bachelor’s degree, preferably in life sciences or related field

Desired Experience, Knowledge, and Skills:

  • 2-5 years of regulatory affairs experience
  • Experience with PMA, IND, and EU applications, supplements, and approvals
  • Strong organizational and follow-up skills, as well as attention to detail
  • General understanding of global and U.S. regulatory processes
  • Excellent project management skills with the ability to multi-task
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Excellent presentation skills, both written and in platform presentation format

 

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