Regulatory Scientist

Womble Bond Dickinson (US) LLP seeks a Regulatory Scientist to lead, coordinate, and assist clients in preparing submissions to the FDA for regulatory product clearance. Through strong leadership and scientific expertise, the Regulatory Scientist will work with the firm’s FDA Regulatory team to support clients of the firm that operate in FDA regulated areas. The Regulatory Scientist will have direct interaction with clients and will have the opportunity to work with our team to grow new FDA regulatory services business for the firm. Some limited travel required.

This position can work remotely, or in a WBD office, but may require a training period which will be determined by the supervising attorney.

Responsibilities:

• Research and writing using evidence-based scientific principles to address complex regulatory requirements for product submissions.
• Consult with clients on regulatory research efforts to support product submissions for current and future products.
• Contribute to the firm’s existing FDA regulatory expertise by identifying new and emerging scientific theories and methodologies and applying expertise to proactively serve clients.
• Maintain awareness and proficiency in FDA regulatory guidance documents and agency best-practices for submissions.

Requirements:

To perform this job successfully, an individual must be able to perform each duty satisfactorily, with attention to detail. Excellent client service is expected. The requirements listed are representative of the knowledge, skill, and/or ability required.

• Advanced Graduate degree in Public Health, Regulatory Affairs, Behavioral Sciences, Statistics, Pharmacology, or Related Field required.
• Experience in a professional setting, preferably a consulting firm or law firm
• Demonstrated writing and communication skills and documented interpersonal abilities
• Strong analytical skills and ability to grasp new concepts quickly
• Demonstrated organizational skills: responsive, efficient, independent and proactive in a very fast-paced environment
• Demonstrated proficiency in Microsoft Outlook, PowerPoint, Word and Excel
• Team player, able to interact effectively with all levels of the organization as well as external clients
• Ability to present herself or himself professionally and understand the importance of confidentiality and highly sensitive, client- and firm-related information