Order #: 102488
Title of Position: Sr Regulatory Affairs Manager
Manages US investigational new drug applications (IND), ex-US clinical trial applications (CTA), new drug applications (NDA) and related correspondence from the US Food and Drug Administration (FDA) and other regulatory authorities. Represents Regulatory Affairs in interdepartmental teams and projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES: • Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and/or compliance issues • Manages the preparation, submission and maintenance of US and Canadian Regulatory applications, including routine amendments, annual reports, IND safety reports, and correspondence to FDA and Health Canada in both paper and electronic format • Works with external vendors to plan, prepare, submit, and maintain CTAs in Europe, Asia, and other regions • Represent Regulatory Affairs in cross-functional clinical development program teams • Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance’s and alignment with study objectives • Manage interdepartmental regulatory matters and provide regulatory guidance to other departments