Seattle Genetics

Associate Director, Regulatory Affairs

Description

Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.

Summary

The Associate Director, Advertising and Promotion at Seattle Genetics is responsible for providing strategic regulatory guidance to compliantly meet regulatory requirements and commercial business needs. This position will review and approve promotional and non-promotional materials for oncology product(s) according to applicable regulations, guidance documents, and internal policies and oversee subsequent FDA submission of relevant promotional materials, acting as the regulatory representative for OPDP interactions. This position will also act as a Regulatory Affairs, Advertising and Promotion reviewer for the Medical, Legal, Regulatory review committee, which focuses on medical and scientific communications for investigational products in the company’s robust pipeline. The Associate Director will report to a Director in Regulatory Affairs, Advertising and Promotion and may manage direct report(s) according to business need.

Responsibilities:

• Supporting or carrying out interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s).
• Contributing to/providing strategic regulatory advice on promotional materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives.
• Managing timelines and resources to achieve stated goals.
• Reviewing and approving consumer and professional promotional materials for marketed products, corporate communications, educational and training materials, via the promotional review committee (PRC) process.
• Reviewing and approving of non-promotional scientific and medical communications for development stage products, via the medical/legal/regulatory affairs (MLR) review committee process.
• Contributing to/providing regulatory advisory submission strategies, preparing communications, and overseeing the timely and accurate submission of promotional materials to OPDP for assigned products.
• Maintaining up-to-date knowledge of US and Canadian regulatory promotional environment by reviewing regulatory guidelines, enforcement letters to pharmaceutical companies, and complaint/dispute activities. Advising internal stakeholders on trends and pertinence to existing company materials/activities.
• Ensuring changes to regulatory authority-approved labeling (US, Canada) are appropriately implemented and reflected in promotional materials.
• Developing departmental guidance and procedures as assigned.
• Designing and conducting departmental training as assigned, including training on FDA/Canadian regulations for advertising and promotion to internal employees.
• Coaching and mentoring junior staff within the department.
• Fostering and facilitating teamwork within the PRC and MLR review processes.

Qualifications:

• Bachelor’s degree (BA or BS) in a scientific or pharmacy discipline required. Advanced degree (MS, MPH, PharmD, PhD, or JD) preferred.
• 3-8 years pharmaceutical industry experience with 2-4 years in Regulatory Affairs, preferably with 1-2 years in Regulatory Affairs Advertising & Promotion.
• Knowledge of FDA promotion and advertising regulations and guidance.
• Knowledge of Canadian promotion and advertising regulations and guidance a plus.
• Experience with regulatory review and approval of direct to consumer prescription advertising.
• Experience with healthcare economic outcome research a plus.
• Understanding of, and experience with, regulatory framework applicable to interactions with healthcare providers, payers, advocacy, and other business partners.
• Ability to analyze and interpret efficacy and safety data.
• Excellent communication, listening, and negotiation skills, the ability to strategically influence business partners. An appreciation of how the commercial objectives of the company can be delivered, while at the same time meeting regulatory compliance standards.
• Leadership skills and demonstrated ability to influence PARC and Regulatory teams.
• Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be innovator of new ideas and best practices.
• Ability to recognize potential problems and identify potential resolutions.
• Outstanding attention to detail.
• Domestic travel may be necessary.

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

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Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 02/08/2019