Director, Regulatory Affairs - Promotional
Regulatory Affairs | Santa Monica, CA | Full Time
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term 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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
The Director, Promotional Review and Labeling Regulatory Affairs position will report to the Vice President of Regulatory Affairs and will be responsible for providing regulatory support for reviewing and approving promotional and medical affairs materials. The candidate will lead and participate in all activities related to (1) labeling and regulatory compliance functions regarding labeling and (2) providing strategic regulatory advice on advertising and promotional materials for products in accordance with business goals and objectives, FDA regulations/guidance, PhRMA guidelines and company policy.
Responsibilities (include but are not limited to):
- Provide regulatory leadership and guidance to the marketing team during the development, review and approval of product labeling and advertising materials
- Work collaboratively with medical and scientific personnel on development and review of materials related to advertising and promotion
- Maintain regulatory expertise in product promotion compliance by keeping current with issued FDA (OPDP) Warning and Untitled letters
- Communicate new regulatory standards pertaining to prescription drug promotion and advertising to brand teams and management, as appropriate
- Develop regulatory best practices, working instructions, SOPs for product promotional activities, to establish standards and consistency across products
- Develop and maintain relationships with other internal departments involved in the product promotion and communication process
- Work directly with the marketing teams from concept through review and approval, up to and including DDMAC/OPDP submissions
- Collaborates with other regulatory colleagues to provide input to study designs and target product label with regard to feasibility of promoting potential data/claims
- Oversee internal review and approval process to ensure that prescribing information is accurate, current and consistent with core labeling
- Manage all aspects of labeling and packaging activities to ensure labeling is compliant with the regulations and ready for product launch
- Maintain compliance for regulatory submissions
- Provide oversight of regulatory document control activities
- Other duties as assigned
- Bachelor’s degree in scientific discipline or related field required, advanced degree preferred
- Minimum of 8-10 years’ experience in a regulatory position within a biotech, pharmaceutical or clinical research organization
- Recent experience participating in the regulatory review of promotional materials for oncology products
- In-depth understanding of US regulations for drug promotion/advertising and/or labeling
- Experience with direct FDA interaction (or other regulatory agencies) required
- Strong team player that has a customer service approach and is solution oriented
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Willingness to think outside of the box and adapt best practices to our small, but growing environment
- Ability to adapt in a constantly evolving environment
- Self-motivated with a strong sense of ownership in areas of responsibility
- High degree of professionalism, ethics and integrity
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Drive and right off the 10. We are able to offer the upside of working in a small, but growing company where everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commiserate to any large corporation. To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls please and no agencies or recruiters.