Associate Director, Regulatory Affairs
One of the fastest growing biotech companies in the US
Opportunity to help develop regulatory affairs business
About Our Client
Emerging company focusing on the development of the best-in-class immunotherapy technology for cancer cure. Teamed up with outstanding immunologists and molecular biologists, they have generated a strong pipeline of Chimeric Antigen Receptor (CAR) product candidates to treat a wide variety of liquid and solid tumors. Founded on the vision that the previous incurable previous incurable cancer will be safely and effectively treated with fine-tuning products generated on our innovative technology platform.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
In this role, you will contribute to the company's mission by providing regulatory strategic oversight for complex products or therapeutic area products to help ensure regulatory compliance of promotional materials.
- Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities.
- Serves as a primary regulatory advertising and promotion reviewer on cross-functional Product Review Committee (PRC) teams for assigned products and provide feedback on.
- All marketing, advertising and promotional materials.
- All related internal sales training materials.
- External disease state communications.
- Corporate materials. Materials developed by Medical Affairs.
- Ensures changes to the US labeling are appropriately implemented into product promotional materials.
- Develops solutions to complex US promotional issues by utilizing scientific, regulatory and therapeutic area knowledge to support business objectives and initiatives while effectively managing business risks.
- Monitors and keeps organization up-to-date on US regulatory promotional environment, including laws, regulations and policies enforced by the regulatory authorities as they relate to labeling, advertising and promotion of pharmaceuticals.
The Successful Applicant
- Bachelor's degree; advanced scientific related degree a plus.
- 5+ years of experience in pharmaceutical industry.
- 2+ years of experience in regulatory review of ad/promo materials.
- Background in prescription drugs and/or biologics.
- Experience in oncology/rare diseases drug development a plus.
- Proven ability to analyze and interpret efficacy and safety data.
- Demonstrate excellent communication skills.
- Excellent organization, detail oriented and multi-tasking skills.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
- Understands the dynamics of the PRC, can get your point across while educating others on the "why" of your recommendation or decisions Creative, flexible team player who can understand the big picture.
What's on Offer
Base salary, annual bonus, benefits, vacation, etc.