Senior Director, Advertising and Promotion Regulatory Affairs
Senior Director, Advertising and Promotion Regulatory Affairs
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 221000 - 286000
1 Vacancy
Job Description
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were not finished yet.
Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
The Senior Director Regulatory Affairs Advertising and Promotion is responsible for developing and executing a regulatory strategy that enables the global business to meet its needs in full compliance. This role is based at Kite a Gilead Company in Santa Monica CA and will report to an Executive Director in Regulatory Affairs.
Responsibilities:
Lead develop and mentor a team of regulatory advertising and promotion professionals including a Review team and an Operations team.
Oversee the financial accountability and resourcing responsibilities for assigned staff.
Advising Company stakeholders on regulatory changes policies and enforcement actions that may impact promotional activities.
Assume a leadership role in advising crossfunctional stakeholders on the promotional regulatory impact of new campaign concepts target or product labeling and to provide strategic regulatory guidance on corporate communications and appropriate preapproval and/or disease education communications with minimal oversight.
Review/approve promotional corporate and other nonpromotional materials focused on cellular therapy for cancer to assess for compliance with the applicable regulations guidance documents and internal policies/best practices.
Represent the regulatory perspective at and chairing the executive promotional review committee (EPRC) which includes cross functional partners from Commercial Medical Affairs and Legal
Enhances collaboration across a matrixed organization while developing and maintaining constructive relationships.
May serve as the companys regulatory liaison to the FDAs Advertising and Promotional Labeling Branch for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.
Characterize the advertising and promotion perspective and rationale at regulatory project team meetings labeling meetings brand team meetings and as needed providing training to crossfunctional colleagues.
Review and interpret enforcement letters keep current with industry changes relating to advertising and promotion interpret new Guidance to Industry and evaluate related internal policies/best practices and processes.
Basic Qualifications
Advanced Degree: Advanced scientific degree (e.g. MD PharmD PhD) with 10 years of relevant experience; OR
Masters Degree: Masters Degree with 12 years of relevant experience; OR
Bachelors Degree: Bachelors Degree with 14 years of relevant experience
Preferred Qualifications:
An advanced degree and at least 10 years of experience in regulatory review of promotional materials for prescription drug and/or biologic products
Relevant oncology experience; cell/gene therapy experience
A solid understanding of clinical study design statistical analyses for promotional claims assessment and comprehensive experience with labeling regulations and U.S./global promotional reviews.
Strong decisionmaking and problemsolving skills demonstrated by complex reasoning and risk management assessments.
A proven track record in influencing crossfunctional teams and engaging effectively with senior management.
Superior project management and presentation skills with the ability to work autonomously with minimal oversight from a senior regulatory affairs professional
Expert level of applied knowledge of applicable Health Authority codes laws regulations guidance and industry standards related to advertising and promotional communications about prescription drugs devices (if applicable) and investigational treatments.
Knowledgeable resource for regulatory advice on promotional corporate and other nonpromotional initiatives in other departments
Direct experience working with FDAs Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch
For additional benefits information visit:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob related characteristics or other prohibited grounds specified in applicable federal state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTFor Current Kite Pharma Employees and Contractors:
Required Experience:
Exec
Employment Type
Full-Time
