The part-time Regulatory Consultant will report to the Chief Medical Officer and is responsible for providing regulatory strategic and operational support for maintaining the lifecycle of current Investigational New Drug Applications and filing of NDA/INDs in eCTD format. Assists in the preparation, review and submission of documents to FDA and other global regulatory agencies. This position may also assist in the preparation, review, and submission of documents for international submissions and reports.
Duties and Responsibilities
Primary activities include, but are not limited to:
- Provide strategic regulatory input.
- Coordinate and oversee the activities of the CRO performing Regulatory operations. Assist in preparing documents for publication and regulatory submissions.
- Prepare cover letters and requisite forms for submissions.
- Direct and participate in routine and non-routine submissions, compilation, and publishing activities associated with generating hard copy and eCTD submissions using dedicated software.
- Work with ex-USA regulatory CROs for foreign regulatory submissions.
- Maintain regulatory document submission files, registry, and tracking systems.
- Follow applicable regulations, including FDA, ICH, and GXP.
- Support the Clinical Operations team with Regulatory guidance as needed (i.e. review of ICFs, IP release, etc.)
- Work with Pharmacovigilance to submit SAEs to regulatory agencies as required.
- Provide Regulatory guidance to cross functional teams as needed to ensure Regulatory compliance.
Education and Experience
- Bachelor of Arts/Science in related field
- At least 10 years’ experience in pharma industry regulatory operations; equivalent training may be considered
- Strong communication skills and working knowledge of applicable software platforms to support activities
- Remote office setting
- Part-time position estimated at approximately 25 hrs/month