Regulatory Specialist

Industry

Science and Research

Advert ID

USA_450126

Location

Bethesda

Job Type

Permanent

Hours

Full-Time

Salary Range

USD70000-85000 per year

No. of Openings

1

Branch Information

Bethesda, MD - (USA) 4800 Hampden Lane Suite 200 MD Bethesda , MD - 20814 Phone : 301-215-6346

ContactNumber

301-215-6346

Job Description

Salary range - $70K (w/Ph.D. and no experience) up to $85K depending on experience



This position requires:

*Preparing scientific and regulatory documents (e.g. clinical protocols, investigator's brochures, informed consent forms, annual reports, investigational new drug applications, new drug applications, regulatory correspondence, and clinical summary reports)

*Ability to prepare investigator/pharmaceutical company meeting minutes required

*Analyze pre-clinical and clinical data, prepare reports

*Perform literature searches and extract information to support regulatory documents

REQUIREMENTS

*M.S. degree or equivalent with 5 or more years of relevant work experience pharmacology, toxicology, biochemistry, molecular biology, immunology, or a related field



OR

*Ph.D. with 1 or more years of relevant work experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, or a related field

*Knowledge of US and non-US regulatory requirements

*Excellent oral, written, and interpersonal skills

*High attention to detail required

*Ability to analyze medical research data and review experimental protocols

*Working knowledge of word processing, Adobe Acrobat, spreadsheet, and database management programs



RS I - 0 years of work experience and meets requirements listed above

RS II - 2 years of applicable work experience, meets requirements listed above, demonstrates independent clinical thinking skills, potential for leadership/management and may supervise staff and/or manage team (s), ability to independently manage complex tasks

RS III - 3 years of applicable work experience, meets the requirements listed above, demonstrates superior critical thinking skills, successfully leads/managers a team and/or supervises staff, oversees and coordinates complex tasks, etc.