The Regulatory Affairs Consultant will provide Regulatory leadership as well as operational oversight for Elacestrant, a novel oral selective estrogen receptor degrader being developed for hormone receptor-positive advanced breast cancer. They will be responsible for devising Regulatory strategy and implementing such strategy - along with the clinical and manufacturing teams and CRO - for completion of the ongoing global pivotal Phase 3 trial RAD1901-308, and all supportive Phase 1 and clinical pharmacology studies to support an NDA filing
Fully remote role, one year contract up for renewal
- Develops, leads, and operationalizes strategy, content, and format for NDA submission.
- Participates in review and approval of all clinical pharmacology and clinical study protocols and CSRs; ensures documents are filed with FDA.
- Advises internal personnel regarding the implementation of the regulatory strategy through non-clinical, clinical, manufacturing, and other processes.
- Participates in and oversees preparation and submission of applications and routine reports including amendments and supplements, as required by internal departments.
- Serves as key Elacestrant Core Team member, as well as Regulatory representative to Joint Development Team with our Development partner.
- Key collaborator with our Companion Diagnostic partner.
- Represents company at all meetings with FDA regarding NDA submission, and other Health Authorities, as requested. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company’s filings.
- Collaborates with our global CRO, and other vendors, on fulfilling all ex-US regulatory obligations for ongoing Phase 3 study.
- Works with our internal Regulatory operations and publishing teams.
Experience and Qualifications:
- Requires a BS degree or equivalent with a Master’s degree or PhD preferred.
- Requires 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience.
- Must have successfully led submission and approval of an oncology NDA within the last 5 years. Work on a more recent oncology NDA is preferred.
- Companion Diagnostic development experience is a plus.
- Must have excellent communication skills – both oral and written.