Consultant, ICO

*Location flexible: office or homebased*- UK, IRL, Amsterdam or Milan

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

The Manager, Regulatory Affairs has responsibility to provide comprehensive regulatory services for clients requiring support for registration and maintenance activities in the respective regions for drugs (including OTC, dietary supplements/NHP), biologics, medical devices and other product types (food, cosmetics, substances). This role involves leading the preparation, filing and maintenance of regulatory submissions as well as management of clients.

The role

• Effectively-prepare regulatory files and provide support for maintenance activities in adherence with applicable legislation, and guidelines facilitating approvals and continued client compliance
• Manages and ensures maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies, clients, and related institutions.
• Lead/attend formal interactions (face-to-face meetings, teleconferences, etc.) with clients and, possibly, government agencies.
• Develops initial or alternative regulatory strategies consulting with their Manager and other resources within the organization. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
• Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
• Lead, participate in and support project teams related to regional filings and maintenance activities across a range of product types.
• Effectively prioritize and complete multiple projects within established timeframes.
• Proactively monitors for new regulatory requirements and shares key learnings.
• This role will be accountable for maintenance of their utilization goal while maintaining an appropriate positive revenue stream. Manage project workflow overseeing progress and completion of projects with team members to facilitate meeting billable percent targets and client deadlines.
• Prepare quotations for projects that may cross multiple service areas within the company and manage projects within budget preparing change orders as needed.
• Proactively improve business processes and tools to facilitate provision of core services.

What you need

• Strong working knowledge of relevant local Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines and medical device guidances.
• Ability to maintain a high level of accuracy and attention to detail
• Effective project management skills
• Demonstrated good problem solving, judgment and decision-making skills with the ability to motivate staff to seek creative solutions to issues surrounding on-time, on-budget and quality consulting deliverables.
• Sound listening, conflict management and negotiation skills.
• Excellent planning, organization, interpersonal, time and change management skills.
• Ability to work relatively independently.
• Proven ability to motivate, mentor and coach others.
• Proven ability to understand and communicate corporate policies and procedures.
• Strategic planning and problem solving skills balanced with awareness of business objectives
• Attention to detail - Identifies and resolves discrepancies across various source documents including published and unpublished documents. Notes and resolves errors in written documentation
• Planning & organizing - Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively. Has a routine or system for completing work. Consistently meets timelines and works within budget. Proactively notifies stakeholders and anticipates workload issues.
• Problem solving & decision making - Demonstrates ability to make sound decisions. Focuses on resolving problems and makes decisions in a timely manner. Promptly notifies staff/team of any problems and any decisions made.
• RAPS certification (US, EU, Canada) beneficial but not essential.
• Knowledge of business development process an asset.