Director/Manager, Regulatory Affairs Merrimack Pharmaceuticals
THIS JOB HAS EXPIRED Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.
The Manager/Director of Regulatory Affairs is responsible for long- and short-term planning and directing of designated regulatory activities.
Responsible for long- and short-term planning and directing of regulatory activities.
Interprets corporate policy, develops and implements strategies for the earliest possible approval of regulatory submission, advises and manages the regulatory teams, and reviews ongoing projects.
Plans, schedules and directs activities and programs through regulatory staff. Negotiates with outside agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of product and services.
Reviews and prepares responses to inquiries from regulatory authorities relating to product registrations.
Monitors and updates national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel. Communicates pertinent changes and updates to regulatory staff and senior management.
Oversees the preparation and submission of applications and routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal department (Manufacturing, QA/QC, Medical, etc.) to update registered product information.
Provides input on budget requirements, and monitors project and program costs.
May hire, train and develop regulatory staff and provide input on associated compensation and department structure decisions.
Director level requires a BS/MS in a scientific discipline and 10 years' experience in a bio/pharmaceutical regulatory department.
Managerial level requires a BS/MS in a scientific field and at least 5 years' experience in a bio/pharmaceutical regulatory department.
||One Kendall Square |
Building 700, Second Floor
Cambridge, MA 02139
THIS JOB HAS EXPIRED