We are looking for a regulatory affairs specialist with experience with IVD/In Vitro Diagnostics.
The Regulatory Affairs Specialist will serve as the primary back-up for In Vitro Diagnostic and Companion Diagnostics projects as part of our Medical Device & Diagnostic Research group.
We are seeking a Regulatory Affairs Specialist specifically with a minimal of three years in Medical Device/IVD/ICD experience along with direct regulatory experience. The purpose of the role to plan, organize and implement Regulatory Affairs input to regulatory projects and/or clinical trials being undertaken by ICON.
Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be concerned with: Agrochemicals, Cosmetics, Foods, Medical Devices and Veterinary products. You may work either alone or as part of a regulatory or cross-functional team depending on the size and nature of project. You will report to Regulatory Project Lead but may act as Regulatory Project Lead if designated. You may also support business development activities.
Overview of the Role
- Recognize, exemplify and adhere to ICON's values which centers on our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 10%) domestic and/or international
- To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines.
- Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
- Undertake all required tasks requested to meet departmental and project goals, as appropriate.
- Participate in regulatory and/or clinical trial project teams as required.
- Plan and track designated project activities including financial tracking under supervision
- Initiate product research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements
- Prepare and/or write scientific and regulatory documents and communication letters to Regulatory Authorities, either alone or in collaboration with Regulatory Project Lead or Functional Experts under supervision.
- Prepare and/or write core regulatory submissions to support clinical trials (Clinical Trial Applications (CTA), Investigational new Drugs (IND), or equivalents), either alone or in collaboration with Regulatory Project Lead or Functional Experts under supervision.
- Prepare and/or write regulatory submissions to support post licensing administration/activities, e.g. preparation of variations to product approval either alone or in collaboration with Regulatory Project Lead or Functional Experts. Support the regulatory assessment of proposed changes under supervision.
- Prepare and/or write elements of regulatory submissions to support marketing authorization applications in collaboration with Regulatory Project Lead or Functional Experts. Support the regulatory assessment of procedure under supervision.
- Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
- Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICON
- Keep the relevant Regulatory Project Lead or designee informed of the progress of project activities at all times
- Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary.
- Liaise and work with colleagues from other departments, clients and, Regulatory Authorities as required.
- Maintain an accurate record of the time associated with each activity.
- Other duties as assigned.
- Develop supporting staff skills, encourage growth and provide regular performance feedback.
- Manage designated regulatory project lead projects in accordance with established timelines, budget, quality standards and/or contractual requirements.
- Lead and motivate staff in the projects where assigned as regulatory project lead
Role Requirements
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions,
· Bachelor’s degree or local equivalent, in the sciences or relevant discipline or equivalent experience qualifications
· A minimum of 2 years’ experience in regulatory affairs or aligned work and in the pharmaceutical or pharmaceutical contract service industry. And experience with IVD/ In Vitro Diagnostics.
· Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
· Good written and verbal communication skills.
· Good written and spoken English.
· Proficient in the use of Microsoft Office.
· Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid driver’s license.
We are a company of 13,500 employees in forty countries globally. We differentiate ourselves by developing innovative solutions to bring life-saving drugs to market faster and in a more cost-effective way to foster better patient outcomes. We are a top five clinical research organization with solid earnings and growth potential. Our belief in excellence is our core value in all that we do for our sponsor partners and the patients that we serve. As a company we strive to exceed our customers’ expectations in drug development solutions.
Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent retirement plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes. We care about our people, since they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. Caring for patients while enjoying what we do and delivering great results is something we can achieve if we know we can count on each other and have a clear vision of where we want to go.
This position is home based anywhere in the U.S.
ICON is an equal opportunity employer – Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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