Department: Regulatory Affairs
Job Title: Sr. Manager Regulatory Affairs
Job Location: Seattle, WA
Requisition #: 2009D4TR
Description:
This position provides regulatory support to the VP of Regulatory Affairs and the Project Team for the review and approval of promotional programs against Regulatory requirements for marketed products. With minimum supervision, the Sr. Manager of RA will manage the preparation and submission of correspondence and applications to regulatory agencies, act as a direct liaison with regulatory authorities to facilitate the prompt review and approval of applications and lead and/or participate in project teams for assigned projects/products. This position will provide regulatory leadership and support for the brand teams in review of promotional materials for prescription drugs. Attend promotional review meetings, review all promotional materials, and provide comments in accordance with marketing timelines and FDA regulations (requires minimal supervision). Independently review and approve simple and complex promotional materials using knowledge and application of promotional regulations and guidances, risk assessment skills, and understanding and application of clinical data for approved and pipeline products. Review and approve submissions to DDMAC related to assigned products. Provide guidance and support to DRA regarding submission activities. Maintain regulatory expertise in product promotion compliance by keeping current with issued FDA (DDMAC) Warning and Untitled letters and attendance at product promotion seminars / workshops. Independently provides guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines. Interprets applicable regulations and guidelines for project team use. Keeps project team abreast of regulatory decisions, issues, potential problems and new regulations.
Job Requirements:
Requires Bachelor’s degree in scientific discipline or equivalent required, a minimum of 8+ years of related experience with a pharmaceutical company (10+ years preferred), CRO, or similar organization with at least 5+ years experience in Regulatory Affairs & experience with Marketed Products. Must have previous DDMAC experience. Three or more years of regulatory experience at a managerial level in the pharmaceutical industry or equivalent. Strong knowledge of the drug development process, preferably in the field of oncology. Working knowledge of eCTD preferred. Knowledge of CFRs, ICH and FDA regulations.
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