Junto HLS has been exclusively retained by the SVP of Regulatory Affairs at a Boutique CRO to recruit a Sr. Regulatory Affairs Specialist.
Please note – This is an impactful position, will work with a former Deputy Director from the FDA and is only one step below Manager within our client where career progression starts with Regulatory Assistant, then on to Associate and Associate II, Specialist then Sr. Specialist and on to Manager.
- May serve as a regulatory lead on an assigned program.
- Provides Regulatory Affairs support in the tracking, preparation, and review of regulatory submissions for investigational new drugs, biologics, and medical devices, including writing/editing, quality control (QC) checks, publishing/compilation, and submission of documents to regulatory authorities.
- Participates in project teams and may coordinate specific regulatory operations publishing/compilation of documents for submission to Regulatory Health Authorities.
- Performs reviews on documents relating to regulatory submissions to ensure compliance with current regulations.
- Interacts with internal regulatory senior staff and vendors to facilitate publishing and submission of regulatory documents to FDA, to other Regulatory Health Authorities, or to Partner.
- Performs initial and ongoing reviews of clinical investigational site regulatory documentation in preparation for release of investigational product to the site and may participate as the regulatory representative for ongoing clinical study programs.
- Assists senior staff to prospectively identify program needs and track team progress (eg, resources, timelines) and notifies senior staff members when scopes of work or timelines need to be revised.
- Assists senior staff in the development and updates to company regulatory affairs standard operating procedures (SOPs), forms, and guidelines.
- Greater Washington DC Area
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.