Senior Regulatory Affairs Associate / Regulatory Affairs Consultant, FSP (Genera

Parexel • Billerica, MA

488d

About The Position

We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant to work closely with one large, dedicated client and provide operational support in the IND/NDA maintenance stage. The Sr. Associate / Consultant will also provide appropriate regulatory guidance to Project Teams for the development of regulatory submissions and be responsible for the overall quality of submissions; manages, reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards. Additionally, a Sr. Associate / Consultant must have a comprehensive understanding of the organization's consulting models and methodologies, as well as profound knowledge within a business context of what services Parexel Regulatory Consulting provides. The role involves providing a broad range of consulting services and working within broad project guidelines to identify, refine, and address client issues and to achieve project objectives. The Sr. Associate / Consultant will provide guidance to project team members on technical/process issues, ensuring the timely performance of work within a project scope to the quality expectations of Parexel and the client. Anticipating the next client need and qualifying opportunities with the client or obtaining introductions to other client decision makers is also a key responsibility. In terms of project execution, the Sr. Associate / Consultant will work within a team environment or individually based on project needs, facilitating issue and conflict resolutions. They will prioritize their own workload and may prioritize the workload of the project team to achieve project scope. The role capitalizes on opportunities to improve project efficiency, results, or team performance and proactively takes action. The individual will leverage information from previous projects or other client work to complete assigned project activities as well as facilitate business decisions, producing quality work that meets the expectations of Parexel and the client. They will also review the work of colleagues for content and quality to ensure the expectations of the client and Parexel are met, manage small projects, and may manage larger project engagements. The consulting activities and relationship management aspect of the role involves demonstrating the use of the organization's consulting models and methodologies, providing a full range of technical and/or business consulting services within their area of expertise. The Sr. Associate / Consultant will complete activities and may delegate activities within project scope and objectives in a timely manner, understanding issues that may impact project profitability, quality, and client satisfaction. They will facilitate client decision-making by framing issues, presenting options, and providing objective business advice, collaborating with colleagues as needed to discuss and facilitate resolution of problems or conflicts. Acting as a trusted advisor to clients and/or project teams on technical and/or process issues is essential, as is developing business solutions addressing specific client needs using best practices and knowledge of the client's business and key industry drivers. The individual will interact professionally at multiple levels, including senior management within a client organization, successfully penetrating executive management levels or other business units within a client organization, and facilitating clients in identifying and addressing their needs.