Description
Position Overview
The Sr. Manager, Regulatory/DDMAC will be responsible for directing the regulatory aspects of review and approval of promotional materials and marketing activities for Abraxis BioScience.
Essential Job Functions
The successful candidate will be responsible for providing regulatory leadership and guidance to the respective teams involved in the advertising and promotion review process to ensure promotional materials and communications with FDA are compliance with applicable regulations and company policies. This position will provide regulatory compliance support for Abraxis BioScience and will provide regulatory representation on the Promotional Review Boards. The Sr. Manager will serve as the primary contact, leading and facilitating communications with the Division of Drug Marketing and Communications (DDMAC) and direct the timely submission of all applicable approved promotional materials to the FDA. The candidate will provide regulatory compliance coverage for major industry-sponsored meetings and will deliver regulatory compliance training to members of the sales and marketing groups within the business units as needed. The candidate will manage the maintenance of records and databases that support communication with DDMAC and will participate in improving existing processes and procedures relevant to the creation, review and approval of advertising promotional and labeling materials for the company.
Critical Performance Areas
Maintain up to date knowledge of FDA regulations and interpretations, DDMAC advisory and enforcement letters and policy issues affecting the biotech/ pharmaceutical industry, and communicate significant changes in DDMAC perspective to internal stakeholders.
Facilitate the timely development and approval of promotional materials by interpreting and applying regulations and guidelines of DDMAC and corporate policies.
Chair PRB and effectively collaborate with Commercial, Legal, Clinical, Medical Affairs to develop and implement effective strategies for DDMAC submissions
Participate in commercial meetings to provide regulatory perspective on draft materials, marketing strategies, implementation, and promotion objectives.
Manage the correspondence with DDMAC and act as the primary liaison with DDMAC.
Participate in policy development and drafting of internal guidelines and SOPs.
Requirements
Requirements
BS Degree in a core science and 7-10 years regulatory affairs experience in the biotech/pharmaceutical industry, including specific knowledge and experience with promotional advertising and labeling regulations.
PharmD, JD, or MS in scientific discipline preferred
The candidate will have experience communicating and negotiating directly with DDMAC and must have sound judgment and strong communication skills.
The candidate will work closely with members of the commercial business units, corporate communications, legal and medical and must be able to influence others and foster team collaboration.
FOR CONFIDENTIAL CONSIDERATION EMAIL RESUME TO: kstevens@abraxisbio.com
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