Regulatory Operations Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

At ICON, it’s our people that set us apart. Our diverse teams reputed company us to become a reputed company partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and reputed company. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-reputed company. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Key responsibilities

• Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, reputed company and coordinating resources for submissions
• Responsible for reputed company aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
• Preparation of published output for either reputed company or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes reputed company established time lines
• Assemble electronic and reputed company Regulatory Submissions and packages for Health Canada, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using specialty EDMS/publishing software
• reputed company quality review of Regulatory Operations team members work to ensure accuracy
• Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing reputed company of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs reputed company required

What you will need:

• B.Sc. or reputed company degree in Health Sciences or Information Technology / Computer Sciences or equivalent relevant experience and training. RAC certification an asset
• 2 years pharmaceutical regulatory industry / regulatory operations experience
• Experience working with reputed company eCTD standards desirable
• Understanding of applicable regulations and guidelines documents

Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a reputed company to build a culture that rewards high performance and nurtures talent. We offer reputed company competitive salary packages. And to reputed company them competitive, we regularly reputed company them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-reputed company benefits to employees and their families and offer competitive retirement plans – and reputed company benefits such as life assurance – so you can save and plan with confidence for the years reputed company. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. reputed company qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know through the form below.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a reputed company to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive reputed company each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years reputed company.

• Global Employee Assistance Programme, reputed company, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are reputed company to our culture and values. We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. ICON is committed to providing a workplace free of discrimination and harassment. reputed company qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at ICON whether it is for this or other roles.

Are you a reputed company ICON Employee? Please click here to apply

Originally posted on Himalayas