Senior Regulatory Consultant - Nonclinical / Toxicology

Are you a Nonclinical professional with a flair for Regulatory Writing?

If so, we have a great home-based opportunity to join Parexel's highly esteemed Regulatory Consulting Services (RCS) team as a Senior Consultant. Our RCS Team provides clients with the strategies and services around defining and executing the most efficient path to obtaining regulatory approval.

As a Senior Consultant, you will be working with a Team of highly experienced professionals with both Industry and FDA experience; you will have the opportunity to work with a variety of clients and products; you will have the opportunity to find solutions and execute on behalf of our clients; you will have the support of a dedicated team of Business Development Professionals; and you will have the opportunity to continue to advance professionally and stretch your own thinking.

A Senior Consultant within RCS 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 RCS provides. A Senior 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 RCS 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 work load and may prioritize the work load of the project team in order to achieve the project scope
Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
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 RCS 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 projects
Interacts with the assigned Project Assistant 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 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 which 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 to discuss and facilitate 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

Qualifications

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 new business/referrals
Identifies opportunities for follow-on business or changes in project scope

We are looking for individuals that have:

7+ years’ experience in an industry-related Regulatory Affairs environment; Pharmaceutical/Biotechnology, CRO, or Consulting industries
Previous non-clinical, toxicology, or pharmacology regulatory writing experience required coupled with past experience interacting and submitting to the FDA
A dedication to public health and a passion for drug development

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

When appropriate, the ability to travel up to 20-30% internationally and/or domestically may be required

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

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.