Specialist, Reg Affairs - Clinical Research

Piper Companies (Health & Sciences) is seeking motivated candidates for a Specialist, Regulatory Affairs opportunity in the Rockville, MD Area for immediate assistance with an established research firm supporting critical research trials. The Specialist will be involved in regulatory operations and support the development of protocols to adhere with the management of clinical trials.

Responsibilities for the Regulatory Affairs Specialist

* Oversight of multiple drug and vaccine Investigational New Drug (IND) Applications including development, compliance review, and submission tracking

* Coordinate all regulatory activities for initial IND Applications, Annual Reports, Amendments & Continual Reviews including protocol review, document compiling, electronic regulatory submission, and timeline tracking

* Lead and participate in projects to optimize regulatory processes and facilitate best practice approaches to ensure compliance in accordance with GCP, ICH, FDA and other Health Authority regulations and governing bodies

* Provide oversight for regulatory activities, database management, and ensure that records are complete, accurate, and current for Trial Master Files (TMF)

* Analyze medical research data, ICF's and CRF's to ensure regulatory and protocol compliance

* Supervise and manage a team of regulatory staff members to ensure regulatory tasks, goals and timelines are met for ongoing trials

* Partner with essential project management contacts to uncover and resolve potential issues and deviations from target timelines

* Identify areas of improvement for work process tools including regulatory templates, SOPs, work instructions, checklists, trackers, etc. and lead the reconfiguration of identified improvement areas

* Engage with internal executive leadership, high level external stakeholders and project teams to ensure effective communication is delivered with all project members

* Perform literature searches, attend meeting and calls to gain regulatory intelligence, strategy development in order to support regulatory document preparation, submissions and identification of regulatory policy changes

Requirements for the Regulatory Affairs Specialist

* 2+ years of clinical research & regulatory affairs experience (must include some infectious disease experience)

* Expert knowledge of GCP, ICH, and FDA clinical research regulations

* IND Application, Annual Report and Amendment submission experience

* Ph.D., MD, PharmD or Master's Degree in related scientific field

Compensation for the Regulatory Affairs Specialist

* Salary Range: $65,000 - $80,000 depending on years of experience

* Benefits Package: Medical, Dental & Vision Insurance, PTO, Paid Holidays, Education Reimbursement

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Keywords:

Good Clinical Practice, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, data management, tmf, trial master file, standard operating procedures, protocols, adherence, sop, IND, Investigational New Drug, management, supervisor, leader, project management, infectious disease, vaccine, drug, regulatory submission, electronic submission, medical research data, icf, crf, protocol review, document compiling, timeline tracking, amendment, annual report, continual review