Associate Director, Regulatory, Advertising and Promotion, Gene Therapy
bluebird bio’s Regulatory Science team is focused on the efficient development of our gene therapy products to bring safe and efficacious products to the market to improve, and hopefully transform, patients’ lives. We have a lot of work to do across our Severe Genetic Diseases Franchise and our Oncology Franchise. Patients are waiting and we know we are making a difference every day when we show-up to the nest!
As Regulatory Science team member, you will work with (*surprise*) the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to improve Regulatory Science. We see regulators as partners. Our core principles are to be transparent and proactive in our communication with them and to use science-based reasoning. Gene therapy is innovative and so are the regulatory birds! If you’re interested in pioneering gene therapy with purpose, come fly with us!
We seek an experienced Regulatory professional (Associate Director or Director) who will be responsible for providing strategic regulatory guidance regarding advertising and promotional materials and other communications including those developed by Medical Affairs.
About the position:
- Strategically assess risks and benefits to ensure compliance of promotional and non-promotional external communication.
- Regulatory lead on the bluebird bio Medical, Legal and Regulatory (bMLR) Review Committee for assigned products for global core materials and US materials
- Direct and ensure the timely submission of all applicable promotional materials to the appropriate regulatory agencies
- Represent the regulatory department with cross-functional partners and communicate regulatory advertising and promotional strategy and risk analysis
- Contribute to process improvement initiatives related to advertising and promotion.
- Contribute to developing Regulatory Science best practices such as work instructions and SOPs for promotional and non-promotional activities to establish standards and consistency across company brands.
- Participate in regulatory intelligence activities; monitor regulatory guidelines and trends
- Advanced degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical fields including bio-chemical engineering
- Minimum 8+ years of regulatory experience in a biotech/pharma company, preferably in biologics
- Minimum 5+ years of regulatory experience in advertising and promotional material review and in medical/legal/regulatory approval processes
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporation of multiple points of view
- Independently motivated, detail oriented and good problem-solving ability
- Excellent organizational skills, ability to multi-task in an extremely fast-paced environment with changing priorities
- Excellent communication skills and ability to influence across multiple functions
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself