Regulatory Strategist

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre 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.

• Supports the submission and maintenance of INDs, NDAs and global submission under guidance from manager and regulatory leads within the department.
• Supports the conduct of clinical trials and other activities, e.g. compliance, throughout the lifecycle of a project.
• Execute and support global regulatory strategies under supervision and direction from manager.
• Works with cross-functional teams to communicate submission requirements, obtain and review technical information for the preparation of IND and NDA Annual Report, safety and information amendments for submission to FDA for proper positioning, context and completeness.
• Ensures all required content for submission are complete and in compliance with company guidelines and regulatory requirements.
• Responsible for achieving routine submissions (e.g. IND amendments).
• Responsible for researching and assisting in the preparation of general responses (formulating and/or editing) for clinical and non-clinical data responses to regulatory agencies.
• Provides regulatory review of clinical trial documents (protocols, reports, etc.) with oversight as identified by applicable SOPs for submission to regulatory agencies.
• Attends study team meetings and provides regulatory guidance on regulatory administrative and logistical issues.
• Assists with preparation for agency meetings and may attend agency meetings to capture minutes.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.

• BSc Degree, preferred. BA accepted.
• Minimum of 2 years of pharmaceutical industry experience. This is inclusive of 2 years of regulatory experience or combination of 1 year regulatory and/or related experience. 
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Basic working knowledge of drug development process and regulatory requirements.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
• Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Must work well with others and within global teams.
• Able to bring working teams together for common objectives.
• Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies

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.