Regulatory and Documentation Specialist

Regulatory & Documentation Specialist

ESSENTIAL JOB FUNCTIONS
1. Administers and maintains the Company's Change Control System for compliance documentation.
2. Administers and maintains the Company's Annual Product Review including generating the reports.
3. Uses Food and Drug Administration (FDA) monographs and other regulations to develop compliant
Drug Facts Box information including active ingredients and concentrations, uses, warnings, directions,
and inactive ingredients.
4. Monitors regulatory activities (via searches of government internet web sites, review of USP
supplements, Federal Register publications, and other government communication vehicles) and
proactively presents, advises, and executes internal programs associated with these activities.
5. Maintains facility licenses and drug listings.
6. Administers the adherence to procedural requirements in the development of Master Records.
7. Review and evaluates product labeling to ensure compliance with all regulations and requirements.

Qualifications:

1. 4-year technical college degree in a specialized preferably in the sciences
2. 4-5 years of experience in a pharmaceutical environment
3. At least 1-2 years of regulatory experience

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.