Careers

To apply for the position below, email your résumé to Lisa Byrne at careers@artisanpharma.net. Emails only, please.

 

Senior Manager/Associate Director, Regulatory Affairs

Position Description:

Primary responsibilities include being the Regulatory Affairs representative for the assigned projects; generation, review and compilation of regulatory submissions and serve as lead on assigned agency communications. This position will develop and implement initiatives aimed to ensure the successful and timely completion of the ART-123 Phase 2b clinical trials and all related clinical trial milestones.

Responsibilities:

Responsible for preparation of quality document packages required for IND amendments, Master files, and other regulatory submissions.
Reviews submission related documents such as safety reports, clinical protocols, Investigator’s Brochure, SOPs, process descriptions, change controls to ensure compliance with FDA regulations and ICH guidelines.
Assists in the development and maintenance of organizational systems for the department’s operational functions.
Ensures quality document filing (electronic and hard copy) of each assigned project
Maintains high level of regulatory knowledge of current GMP, GLP, and GCP regulations.
Monitors the issuance of revised and new FDA & ICH regulations concerned with biologics.
Assist Senior VP of Regulatory Affairs and Quality Compliance in activities associated with liaison to external collaborators, and scientific institutions/associations on regulatory issues.

Requirements:

“Hands on” experience in preparation of IND amendments, annual reports and/or BLA supplements
Very familiar with the current regulatory guidelines (US FDA, ICH preferable)
Superb document production capabilities
Bachelor’s degree or equivalent
RAC certification is a plus but not essential
3-5 years hands on experience in Regulatory Affairs in the pharmaceutical and/or biotechnology industries is preferred, as is knowledge of FDA regulations and submissions procedures
The candidate should possess proven general administration capabilities, including good written and oral communications skills, as well as advanced computer skills geared toward electronic document publishing

ART-123 is a novel, recombinant, soluble, human thrombomodulin being developed for the treatment of DIC (disseminated intravascular coagulation) in sepsis and DVT (deep vein thrombosis). ART-123 uniquely targets both coagulation and systemic inflammatory pathways and holds great promise as a self-regulating treatment of DIC in sepsis. Phase 3 studies have been completed for ART-123 in Japan for DIC and the product recently filed a Japanese NDA. Artisan plans on initiating Phase 2b studies of ART-123 for DIC in sepsis in the US early next year. Approximately 1.8 million patients in the United States and Europe suffer from sepsis annually, with approximately 30 percent of them developing DIC. For those that do, prognosis is poor.

Artisan Pharma is a Drug Free Workplace and pre hire drug screening will be preformed.