We are seeking an experienced contract Regulatory Generalist to join our client, in the biotechnology / life science, as a Senior Regulatory Affairs Associate or Regulatory Affairs Consultant.  This position will work closely with one large, dedicated client and Regulatory Specialist to provide operational support in the IND/NDA maintenance stage. The Sr. Associate / Consultant will 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 consulting provides. A Consultant develops specialist knowledge of a particular subject matter or market.

• Provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.
• Provides guidance to project team members on technical/process issues
• Ensures the timely performance of work within a project scope to the quality expectations of PC and the client
• Anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision-makers.

Project Execution

• Works within a team environment or individually based on the project needs
• Works within broad project guidelines and facilitates issue and conflict resolutions
• Prioritizes own workload and may prioritize the workload of the project team to achieve the project scope
• Capitalizes on opportunities to improve project efficiency, results, or team performance and proactively acts
• Leverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisions
• Produces quality work that meets the expectations of consulting and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
• Manages small projects and may manage larger project engagements
• Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support
• Provides guidance to project team members, and acts as a mentor to junior staff

Consulting Activities and Relationship Management

• Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
• Provides a full range of technical and/or business consulting services within the personal area of expertise dealing mainly in areas where policy or precedent is clear
• Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues that may impact project profitability, quality, and client satisfaction
• Facilitates client decision making by framing issues, presenting options, and providing objective business advice
• Collaborates with colleagues, as needed, to discuss and facilitate the resolution of problems or conflicts. Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities
• Acts as a trusted advisor to clients and/or project team on technical and/or process issues
• Develops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
• Interacts professionally at multiple levels including senior management within a client organization

• Successfully penetrates executive management levels or other business units within a client organization
• Facilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
• Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
• Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management

To ensure success, we are looking for individuals that have:

• 3-5+ years’ experience in an industry-related environment; Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries. Previous CRO experience is a plus
• 3+ years of experience in General Regulatory Affairs with previous experience in the preparation and leadership of teams for IND and NDA submissions to include reviewing and/or writing sections of IND and/or NDA applications from a clinical, nonclinical, or CMC regulatory perspective for a Sr Associate role and 5+ years of experience for a Consultant role
• Previous experience preparing regulatory materials for meetings
• Candidates with previous experience defining RA strategies are highly preferred for consultant level roles
• Previous small molecule experience is highly preferred
• Knowledge of FDA processes and regulations
• Familiarity/experience with FDA interactions (verbal or written) is required
• Experience with project lifecycle and management
• Medical device experience is a plus

Education - Minimum of a bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree Preferred

Language Skills - At least fluent vocal and written English

Travel Required - up to 30% Domestic or International may be required in the future dependent upon clients' needs

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.