Regulatory Affairs Intern

Job Description

Position Summary

The Regulatory Affairs Intern assists with compilation, preparation, and organization of regulatory related documents and reports. This position is responsible for supporting the maintenance of Chemistry, Manufacturing and Control sections of regulatory submissions to global and domestic regulatory agencies.

Major Roles & Responsibilities:

• Maintains an understanding of assigned current federal, state, local and/or company regulations applicable to BioSpectra and BioSpectra products as assigned by management.

• Supports with the Compilation of Modules 1, 2 and 3 of the eCTD filings.

• Assists with ensuring drug master files, veterinary master files, and active substance master files are current through review of internally available documentation.

• Assists with ensuring all BioSpectra Change Controls are included in Regulatory Submissions in a timely manner through review of the internal index and current submissions.

• Files and Archives Regulatory Documents as required.

• Assists with the retrieval of support documents for drug substance listing for filing to the US FDA or other global regulatory agencies as required.

• Assists with ensuring Good Documentation Practices are followed on all regulatory submitted documentation.

• Assists with preparation of all regulatory documents as assigned by management.

• Assists with regulatory inspection action items.

• Assists with ensuring Regulatory Requirements in Customer Quality Agreements are maintained in compliance for submissions.

• Assists with the development and evolution of the Regulatory Program procedures and policies.

• Other duties may be assigned as deemed appropriate by management.

Qualifications:

• Student enrolled in a Bachelor's or Graduate Program in a science-related field

• Ability to define problems, collect data, establish facts and draw valid conclusions

• Experience with relevant software applications including MS Office, Excel, and Adobe

• Ability to communicate effectively with staff and management

• Ability to handle sensitive information in a confidential manner

• Close vision, distance vision, ability to adjust focus, ability to distinguish color change, and the ability to use a computer for extended periods of time.

Physical Requirements:

• Standing for extended periods

• Walking for extended periods

• Sitting

• Keyboarding

• Regular lifting of up to 10 lbs.

• Occasional lifting of up to 25 lbs.