Regulatory Affairs/Quality Assurance Associate

Insmed Incorporated is a biopharmaceutical company, located in Richmond, Virginia, with manufacturing facilities in Boulder, Colorado that is focused on the development and commercialization of drugs for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. Our lead compound, IPLEX™, is an orphan designated biologic product that is approved in the US for the treatment of severe primary IGF-1 deficiency (IGFD) and is currently in Phase II clinical development for a number of other endocrine disorders. Our second product candidate, rhIGFBP-3, is a biologic product currently in Phase I clinical development that has shown promising anti-tumor efficacy in several animal models.

We are currently seeking a clinically focused (GCP) Regulatory Affairs/Quality Assurance Associate to join our Regulatory Affairs department with responsibilities for coordination, preparation/writing and review of regulatory submissions (NDAs, INDs, MAAs, CTDs, etc). This position will report to the Director, Regulatory Affairs. The responsibilities of this position include, but are not limited to:
•Compiling and reviewing all materials required in world-wide regulatory submissions, license renewals and annual registrations;
•Recommending changes for labeling, manufacturing, marketing and clinical protocols;
•Monitoring and improving tracking/control systems;
•Keeping abreast of world-wide regulatory procedures and changes;
•May have direct interaction with regulatory agencies on defined matters;
•Recommending strategies for earliest possible approvals of regulatory submissions;
•Planning and executing a comprehensive QA Audit Plan;
•Assessing company’s performance relative to protocols, SOPs, and ICH/GCP Guidelines;
•Identifying and Assessing risks based upon audit findings;
•Driving corrective and preventive action based upon audit findings as well as upon knowledge gained in the course of other duties;
•Ensuring that company is always poised for regulatory inspection, and taking a leadership role during inspections
•Assisting with SOP review and development;
•Acting as liaison with other departments in the Company for matters of regulatory compliance.
REQUIREMENTS
•Bachelors/Masters degree in a scientific discipline with 2-5 years Regulatory Affairs experience in the pharmaceutical/biotech industry or a CRO
•Experience in GCP required, with experience in GMP or GLP a plus.
•Knowledge of FDA, EMEA and ICH regulations and guidelines.
•International experience helpful.
•Strong computer skills, technical education and training.
•Excellent communication and organization skills.
•Ability to work with minimal supervision.
•RAC certification a plus.