Regulatory Affairs Associate

The Regulatory Affairs Associate is responsible for assisting the Manager of Regulatory Affairs with activities necessary for general regulatory maintenance / surveillance of products in a timely manner.

This Regulatory Affairs Associate will assist with collecting thorough & factual, data & information to complete product registrations or submissions and provide support to product development projects as assigned.

QUALIFICATIONS

Minimum Requirements:

• Bachelor's Degree in Life Science related discipline
• 0-2 years work-related experience in FDA regulated industry
• Understanding of FDA regulatory requirements
• Strong knowledge of Word, Excel, and PowerPoint
• Excellent verbal, written communications skills
• Strong attention to detail, convey information clearly, concisely, accurately, and effectively.
• Excellent interpersonal skills necessary to establish and maintain effective working relationships
• Ability to work effectively in a team environment
• Good organizational and time management skills.

RESPONSIBILITIES

• Coordinating and completing stability program reports.
• Maintaining the proof-of-life stability reports database and follow-up with individual labs and lab reports.
• Assist with drug registrations with the FDA for existing products.
• Coordinate internal audit program, including, maintaining and monitoring the reports, finalizing and closing out the audits.
• Develop SOP's in accordance with the organizational practices and compliance
• Assist packaging claims and with artwork approval process.
• Assist with cGMP training program (scheduling the training for employees, and that the training material are up to date).
• Work at the direction of the Regulatory Manager on other special projects as they arise.

Other Support:

• Assist with activities necessary for the timely preparation for project deadlines
• May be required to conduct basic research and analysis, as required.
• Assist fellow coordinators, as required.

About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. Aerotek is acting as an Employment Agency in relation to this vacancy.