Sr Regulatory Strategist

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Qualifications

What do you need to have?
• Bachelor's Degree
• 5 years of relevant experience
• Strong knowledge of regulatory requirements, guidances and environment for product development, new registrations and lifecycle maintenance activities, with supervision.
• Good knowledge of content requirements for regulatory submissions.
• Strong knowledge of drug &/or device development and lifecycle.
• Strong knowledge of review and approval processes of applicable regulatory Health Authorities / Notified Bodies.
• Basic knowledge of how the pharmaceutical/device industry works.
• Excellent written and oral communication skills.
• Excellent attention to detail.
• Demonstrates strong ability to have a flexible approach and adapt to change.
• Strong ability to plan, organize and deliver on assigned projects, according to agreed deadlines.
• Strong ability to understand complex issues.
• Good ability to apply skills to determine risk exposure and communicate potential issues to management.
• To qualify, applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status. Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Responsibilities

What will you be doing? The Senior Regulatory Strategist is responsible for the regulatory strategic and consulting aspects of PRA's service offerings to sponsors from early development and throughout the commercial lifecycle.Works with regulatory team members to facilitate life cycle maintenance activities
• Prepares FDA forms and cover letters (CL) required for US IND, BLA and NDA submissions and performs a quality check (QC) of Regulatory published submission output file to ensure links are working, and content conforms to content plan
• US Support provides support for setting up meetings for submissions, inviting the relevant stakeholders and recording meeting minutes and action items if requested by regulatory lead for submissions, responses to questions and briefing books - Kick-off - Roundtable discussions weekly until submission. - Supports meeting prep as needed
• Manages regulatory timelines for activities
• Prepares templates
• Uploads meeting minutes and work-in-progress templates to program SharePoint sites and systems as necessary.
• Coordinates the tracking of dossier compilation, submissions and approvals for assigned products in various phases of clinical development, global marketing applications and post-approval life cycle activities, with minimal supervision.
• Supports the development of the Regulatory Strategic Plan throughout the lifecycle of the product, with supervision.
• Supports requests from SMEs relating to preparation activities for meetings with Health Authorities /Notified Bodies as required and with moderate supervision.
• In liaison with global, regional and local SMEs, supports planning for global submission of new product registrations and preparation of appropriate dossiers for all targeted countries / regions, withmoderate supervision.
• Assists with notification of project team colleagues, functional management, and key stakeholders of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Actively seeks opportunities for personal growth and development and monitors progress towards achieving development goals, with guidance from functional manager.
• Leads team members, with some supervision, to achieve operational and strategic plans
• Demonstrates an understanding of the core business objectives and the role of other functional areas.
• Applies knowledge of ICON policies and procedures at all times.

United States-Remote
Canada-Remote
Canada-Remote