Rachel E. Melman

Oversee regulatory strategy for the cardiovascular portfolio for preclinical through Phase 3 programs.

Oversaw regulatory strategy for the cardiovascular portfolio for preclinical through Phase 3 programs.

Clinical Regulatory - Oversaw and managed regulatory activities for multiple clinical programs (Phase 1-Phase 3 studies) - Advised study teams on regulatory strategy - Liaised with Regulatory Affairs counterpart at partner company - Led preparation for multiple regulatory meetings Commercial Regulatory - Developed processes for and served on medical affairs review committee - Worked with Corporate Communications to define social media guidelines and reviewed social media posts

Regulatory Affairs Lead for multiple programs: - Managed CTAs in North America and Europe for Phase 3 clinical study - Advised study teams on regulatory strategy - Liaised with Regulatory Affairs counterpart at partner company - Developed global regulatory plan

Regulatory Affairs Lead for two international, phase 3 clinical studies: - Managed clinical trial applications and maintenance submissions world-wide - Reviewed clinical site documentation to authorize shipment of clinical drug supplies - Advised study team on regulatory strategy Promotional Review Committee: - Managed review committee administration - Reviewed materials for promotional and internal use for regulatory compliance - Prepared materials for OPDP submission - Managed transition from paper-based review process to electronic review process Publications: - Performed regulatory review of manuscripts, abstracts, posters, and presentations Medical Affairs Review Committee: - Served as back-up regulatory representative

Promotional Review Committee: - Reviewed materials for promotional and internal use for regulatory compliance - Prepared materials for OPDP submission Performed regulatory review of external communications, including abstracts, manuscripts, and posters. Served as Regulatory Affairs representative for clinical study and risk management teams. Advisory Committee: - Prepared and coordinated review of briefing document - Served as a member of the slide triage team at the advisory committee meeting, including development of Q&A session slides. NDA Preparation: - Prepared and submitted PDUFA User Fee Waiver - Reviewed clinical study reports and Module 2 summary documents - Prepared CTD Introduction, including electronic navigational aids for reviewers

NDA Preparation: - Prepared Module 1 documents, including pediatric studies waiver and deferral, financial certification and disclosure, and other certifications - Coordinated and participated in review of documents with corporate partner - Developed high-level tracking spreadsheet for senior management use Compiled and submitted routine regulatory submissions including Expedited Safety Reports, New Investigator updates, and IND Annual Report.

Compiled and submitted routine regulatory submissions including Expedited Safety Reports, New Investigator updates, and IND Annual Report. Performed regulatory research on topics such as establishment registration listing, pediatric wavers and deferrals, and orphan drug designation. Made presentations regarding new biosimilar legislation, operational work plan with corporate partner, and DDMAC (now OPDP) enforcement patterns to relevant audiences.

Assembled INDs in eCTD format and managed the conversion from paper submissions to electronic submissions.

Drafted, assembled, and filed original documentation and submission materials to FDA for products in line with business plans and timing needs. Coordinated all aspects of regulatory submissions, including regulatory workflow, reviewing technical documents, tracking submission timelines, and preparing regulatory submissions to ensure compliance. Represented Regulatory Affairs on cross-functional project teams. Communicated regulatory requirements and impact of regulations to the development team to ensure compliance for product development. Reviewed changes in CMC, Nonclinical and Clinical areas to assess the regulatory implications of the changes or findings.

Team Masters Project: Customer and Business Validation for Development of Molecular Diagnostic Testing, Beckman Coulter Emphasis: Clinical and Regulatory Affairs

Emphasis: Tissue Engineering