Regulatory Submissions Manager

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Job description

Responsibilities:

Planning, compiling, publishing and submitting Regulatory documents for IND, NDA, BLA, IDE, and PMA applications, including Amendments, Supplements, and Meeting materials to the FDA.

Reviewing submission components for quality and completeness.

Assuring all electronic submissions are following regulatory requirements and ICH eCTD specifications.

Maintaining Regulatory submission and correspondence archive/records.

Providing publishing support to the Medical Writing group, as requested.

Providing regulatory support to other departments, as requested.

Assisting Sr. Director of Regulatory Affairs in providing regulatory strategy, intelligence, and other regulatory support to product development teams.

Serve as a point of contact for the FDA.

Requirements:

Have a Bachelor's-level degree in science/health related field or a combination of education and industry experience.

Have at least 7 years of experience in Regulatory Operations/ electronic submissions.

Technical knowledge and high proficiency in eCTD compliant submissions and experience with off-the-shelf publishing software is highly desirable.

Some Regulatory writing experience is also desired, such as experience with IND Annual Reports, meeting briefing packages, and regulatory responses.

You should have a good understanding of FDA's submission requirements and drug/ biologic/ device development processes.

Good oral and written communication skills, detail-oriented, self-directing, and ability to handle multiple projects across all functional areas independently are essential.

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