Sr. Regulatory Specialist

PRIMARY OBJECTIVE OF THE POSITION:

The primary duties of this position are to compile, publish and submit eCTD compliant regulatory dossiers to the FDA and other health authorities in a timely manner, and provide Regulatory support to project teams.

QUALIFICATIONS:

The candidate should have a BS degree preferably in a scientific discipline (or equivalent knowledge and experience) and a minimum of 3 years’ experience in Regulatory Operations/electronic submissions.  Technical knowledge in eCTD compliant submissions and experience with off-the-shelf publishing software is highly desirable.

Good understanding of FDA’s submission requirements and drug/biologic/device development processes is required.  Good oral and written communication skills, detail-oriented, self-directing, and ability to handle multiple projects across all functional areas independently are essential.

MAJOR RESPONSIBILITIES AND DUTIES:

  • Plan, compile, publish and submit Regulatory documents for IND, NDA, BLA, IDE, and PMA applications, including Amendments, Supplements, and Meeting materials to the FDA.
  • Review submission components for quality and completeness.
  • Assure all electronic submissions are in compliance with regulatory requirements and ICH eCTD specifications.
  • Maintain Regulatory submission and correspondence archive/records.
  • Provide publishing support to the Medical Writing group, as requested.
  • Provide regulatory support to other departments, as requested.
  • Assist Regulatory Director in providing regulatory strategy, intelligence, and other regulatory support to product development teams.
  • Serve as a point of contact for the FDA.