Regulatory Operations Associate

Industry

Health and Safety

Advert ID

USA_450134

Location

Bethesda

Job Type

Permanent

Hours

Full-Time

Salary Range

USD48000-55000 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

REGULATORY OPERATIONS ASSOCIATE (up to 5 positions)

Salary range - Regulatory Operations Associate: $48K -$55K depending on experience

RESPONSIBILTIES

*Prepare standard documentation supporting regulatory filings and distribution to stakeholders.

*Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.

*Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.

*Draft, edit, and distribute various documents as needed based on templates and work instructions.

*Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.

*Track regulatory activity, maintain and update databases, and ensure that records are complete and current.

*Provide other administrative regulatory support as needed.



REQUIREMENTS



*B.A./B.S. Degree with a minimum of 0 - 2 years' work experience.

*Must have excellent attention to detail; verbal and written communication skills.

*Superior organizational skills and customer service abilities are required.

*Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred.

*Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.

*Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.

*Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable.

*General knowledge of the drug and vaccine development process or clinical trials is a plus.