| clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer. |
Department Marketing Statement:
The Regulatory Affairs Department is a dynamic, creative and collaborative function with a mission to create and execute regulatory that bring more cures to patients. We do this by being an open-minded organization dedicated and entrusted to represent their best science to regulatory agencies and show our commitment to patients. We have regulatory expertise in cell and gene therapy and are searching for talented and driven individuals with commercial experience who are excited to help build a well respected, transparent and strategic regulatory function.
The Director of Regulatory Affairs Advertising, Promotion and Labeling will be responsible for providing strategic regulatory advice and oversight of advertising and promotional materials, external communications, and labeling. The Associate Director acts as an integral member of cross-functional teams that develop and implement the strategy for materials including promotional materials, sales training materials, press materials, patient materials, and labeling for marketed and investigational products, as relevant. This role will serve as the lead regulatory affairs representative on the promotional materials review committee and will run the promotional review and approval process.
- Provide regulatory leadership, including strategy and guidance and work directly with the stakeholders (such as Marketing, Medical Affairs and Legal) from concept through review and approval of promotional materials and activities ensuring compliance with corporate policies, federal regulations and guidelines, and product development objectives
- Provide regulatory leadership and guidance to the teams during the development, review, approval and maintenance of product labeling materials
- Oversee timely and accurate submission of promotional materials to OPDP
- Ensure that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising
- Provides strategic guidance on labeling requirements and competitor labels
- Works with therapeutic lead on the development of target product labeling
- Provide a leadership role on the promotional materials review committee for regulatory review of patient materials, sales training as well as advertising and press materials and labeling supplements for marketed and development programs as relevant
- Strategically assess risks and benefits of promotional and non-promotional communications and establish risk parameters for communications activities by influencing cross-functional teams to develop a common vision of benefits and risks
- Provide leadership for effective decision-making, planning, and project management for training of company team members
- Clearly and efficiently analyze issues and communicate options in the face of ambiguity
- Over time, effectively plan for, build, maintain and motivate a team
- Possess supervisory and mentoring experience for the development of staff
- Contribute to organizational effectiveness and initiatives
- Effectively serve as a role model within regulatory and cross-functionally
- Willingness to collaborate and problem solve
- Ability to impact industry and agency organizations
Doctorate degree and 2 years of Regulatory and Compliance experience OR Master’s degree and 6 years of Regulatory and Compliance experience OR Bachelor’s degree and 8 years of Regulatory and Compliance experience
- Experience with US commercial products highly desired.
- Ability to work in fast paced environment
- Strong leadership and communication skills
*Position can be located in either San Francisco, CA or Seattle, WA*
Company WILL RELOCATE (and provide Boomerang Relo- If you do not like Seattle or San Fran in 2 years they will move you back)!-FULL package!
Bonus, stock, and more! salary 175-215k, plus 20% bonus
Send your cv and cover page