Senior Consultant, ICO

ICON is currently recruiting for a Manager, Regulatory Affairs to join our Strategic Regulatory & Safety Consultancy group that forms part of a wider Commercialization and Outcomes group. Our regulatory consulting team serves clients around the globe—from biotech startups to big pharma—as well as the research firms that serve them. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff.

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 pharmaceuticals,  biologics, medical devices  and other product types.  This role involves leading the preparation, filing and maintenance of regulatory submissions as well as management of clients.

This role  is  responsible for ensuring  project/  program  timelines and budgets  are  met and  maintaining  client  relationships  in  support of future  business.  The role is responsible for support of activities to secure new clients/business.  This position may or may not have direct reports.

Location: US or Canada can be office or home based

Responsibilities & Accountabilities:

•          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 government agencies
•          Develops initial or alternative regulatory strategies consulting with their manager and other resources within the organization as needed. 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 project 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 monitor for new regulatory requirements and share key learning
•         Train or mentor others to build team expertise across various product types
•          This role will 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 process and tools to facilitate provision of core services
•          Ability to work off site at client occasionally may be needed
•          Ability to travel (10%) as necessary, passport required

Required Qualifications:

•         Undergraduate degree preferably in science, nursing, or healthcare field or equivalent qualification/experience, relevant advanced degree preferred (MS, Ph.D., MD, Phar.D., MBA)
•          Certification in regulatory affairs (RAC) or postsecondary institution beneficial
•         Minimum if 6 years of relevant experience i.e. pharmaceutical, biologics, medical device
•         Experience in consulting, supporting business development activities and people management is beneficial

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment

*LI-SB1