| Job Description: |
The primary purpose of this role is to:
Lead the marketed products effort within Regulatory Affairs to maintain approved BLAs/NDAs and provide regulatory review of promotional and educational materials
Represent Seattle Genetics to regulatory authorities
Represent Regulatory Affairs on various product teams, and lead the product labeling teams
Coordinate and prepare document packages for regulatory submissions, including determination of both content and regulatory context
Reports to the Senior Director, Regulatory Affairs
Specific responsibilities include:
Prepare and submit BLA/NDA supplements, annual reports, advertising and promotional materials, and other submissions to FDA that are required for BLA/NDA compliance for marketed products.
Interact with regulatory agencies to facilitate approval for product, manufacturing, and labeling changes.
Direct post-marketing regulatory activities, including routine interactions with DDMAC and regulatory agencies regarding post-marketing subject matter.
Develop and/or maintain core labeling documents and regional labeling for regulatory authority review and approval.
Advise Sales/Marketing and Medical Affairs staff on regulatory issues and impacts of promotional activities.
Provide regulatory oversight in the development, review, and approval of advertising and promotional materials, and provide guidance in the development of compliant sales training, advertising and detail literature.
Provide regulatory oversight in the development, review, and approval of presentations and materials to be used by medical liaisons and other scientific staff.
Manage post-market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported and preparing and submitting expedited safety and periodic safety reports to FDA. Requirements B.S./M.S. in Life Science (PhD or PharmD preferred) with a minimum of five to eight (5-8) years regulatory affairs experience
Prior regulatory experience with US BLA/NDA maintenance activities including periodic reports, supplements, labeling, promotion and advertising reviews, strategy for marketed products, and interaction with DDMAC
In depth understanding of regulatory processes, procedures, guidelines and regulations
Must be able to function as the regulatory expert on post-marketing submission maintenance, advertising and promotion
Good understanding of the drug development process
Excellent communication skills and a proven ability to negotiate with regulatory agencies
Experienced in presenting information at internal and external meetings
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