Regulatory Affairs Specialist (Remote/United States)
Location: United States
Requisition Number: 992
Position Title: Specialist, Regulatory Affairs
Site Activation is a fast growing, dynamic department! We are the launch pad for new projects. We help determine strategies for the optimal mix of countries, target sites and other factors to expedite regulatory and recruitment objectives, and then execute that strategy by initializing regulatory filings and locating, qualifying and activating clinical research sites.
The Site Activation group is the perfect place to launch or further your career. We emphasize development of project management and strategic planning skills that will advance you though the opportunities within Site Activation or serve as an excellent pathway to advancement in Project Management or other Clinical Operations groups.
The Specialist, Regulatory Affairs will act as a local representative to streamline communication between the Worldwide Clinical Trials Regulatory Strategy team and the local/national Ethics Committees and Health Authorities.
Tasks may include but are not limited to:
- Stay abreast of changing regulatory legislative requirements and maintain regulatory intelligence database for assigned territories.
- Provide timely updates and communication of changes in the regulatory environment to the Regulatory Affairs department.
- Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives.
- Provide the RAL advice on appropriate regulatory strategies.
- Liaise with the RAL, CSSL, RCL and SCL to plan, organise, compile progress, track and submit regulatory submissions on a timely basis.
- Act as a Regulatory Affairs Lead for local projects conducted only in the assigned territories.
- Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc.…to ensure compliance with ICH GCP & country specific requirements.
- Act as a contact point for translation review of submissions documents such as application, synopsis, ICF and labels etc., where study specific CRA is not assigned.
- Where required provide local QC of submission dossiers prior to dispatch.
- Comply with SOPs, ICH GCP and national regulations as applicable.
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers.
- Maintenance of country specific patient information sheet and consent form customization text.
- Maintenance of country specific drug labeling information.
- Maintenance of Country Intelligence Pages.
- Effectively communicate status of submissions with the Regulatory Affairs Lead assigned to the project.
OTHER SKILLS AND ABILITIES:
- Clearly, proven organizational management skills are essential attributes.
- Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
- Excellent written and verbal communication skills to clearly and concisely present information.
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment.
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
- Excellent self-motivation skills.
- Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint.
- Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience.
- Previous experience within the pharmaceutical/CRO industry.
- Good knowledge of ICH GCP, EU Clinical Trials Directive.
- Fluency in local language and working knowledge of English.
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Regulatory Affairs Specialist (Remote/United States)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.