• Detail-Oriented
• Proactive
• Problem-Solver
• Results-Driven
• Organized
• Multi-Tasker

Tremendous opportunity for a Regulatory Affairs Generalist to join Parexel's highly recognized Regulatory Consulting Team!

We are seeking an experienced Regulatory Generalist to join our team as a Senior Regulatory Affairs Associate to work closely with one large, dedicated client and provide operational support in the IND/NDA maintenance stage. The Senior Associate 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 EMA to assure compliance with regulatory standards.

Parexel Regulatory Consulting provides.

• 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

• Prioritizes own workload 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

• 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 personal area of expertise dealing mainly in areas where policy or precedent is clear

• Facilitates client decision making by framing issues, presenting options and providing objective business advice

• Acts as a trusted advisor to clients and/or project team on technical and/or process issues

• Facilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems

• Identifies opportunities for follow-on business or changes in project scope with Parexel Regulatory management and account management

Skills and Experience required for the role:

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

• 3+ years’ experience in an industry-related environment; Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries

• 3+ years of experience in General Regulatory Affairs with previous experience in the preparation of IND, CTA, MAA, NDA submissions to include reviewing and/or writing sections of applications from a clinical, nonclinical, or CMC regulatory perspective

• Submission and maintenance of official local drug information, including Patient Information Leaflets, USPI, SmPCs, packaging texts, RMPs and their Educational Material.

• Review, preparation and filing of post- approval license variations/ amendments

• Assists senior RA team members with new NDA/ MA submissions e.g. Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness

• Knowledge of FDA and EMA processes and regulations

• Familiarity/experience with FDA and EMA interactions (verbal or written)