My client is a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases. They have engaged us to find an Associate Director (or Director) of Regulatory Advertising & Promotions who can provide strategic regulatory guidance regarding advertising and promotional materials and other communications. In this role, you will support upcoming product launches of innovative gene therapy programs and direct submission of applicable materials to the regulatory agencies. This company offers a fun, dynamic culture, competitive compensation, and excellent employee benefits.
- Assess risks and benefits to ensure compliance of promotional and non-promotional external communication.
- Serve as regulatory lead on the Medical, Legal and Regulatory 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, communicating regulatory advertising and promotional strategy and risk analysis.
- Contribute to process improvement initiatives related to advertising and promotion.
- Contribute to developing Regulatory 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.
Knowledge & Skills:
- BA or BS in a scientific field is required. Advanced degree preferred (MS, PhD, PharmD).
- Minimum of eight years of regulatory experience with five or more years in Regulatory Advertising & Promotions.
- Promotional review, regulatory compliance, and product launch experience is a must.
- Experience working with health authorities (OPDP or APLB) required.
- Prior experience in medical/legal/regulatory approval processes for biologic programs preferred.
- 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.