Job Summary:

The Regulatory Affairs Manager monitors the companys production activities and ensures compliance with applicable regulations and standard operating procedures.

Supervisory Responsibilities:

• May supervise daily workflow of Regulatory Affairs specialists or other staff.

Duties/ Responsibilities:

• Develops strategies to ensure the companys production activities comply with government regulations.
• Serves as a liaison between regulatory bodies and operating divisions of the company.
• Prepares and submits applications and reports to applicable regulatory agencies.
• Responds to requests for information from regulatory bodies.
• Coordinates with operations departments regarding production design and development to ensure compliance with regulations.
• Assists with the development of standards for the companys operating and production procedures.
• Maintains current knowledge of regulations applicable to the company.
• Monitors regulatory affairs and the effect changes will have on company operations.
• Develops and maintains professional relationships in federal, state, and local regulatory agencies.
• Performs other related duties as assigned.

Required Skills/Abilities:

• Extensive knowledge of applicable government regulations.
• Ability to inform and educate managers and department heads on regulations and polices that require compliance.
• Excellent written and verbal communication skills.
• Excellent analytical and problem-solving skills.
• Excellent strategic planning skills.
• Proficient with applicable database and compliance software.
• Proficient with Microsoft Office Suite or similar software.

Education and Experience:

• Bachelors degree in Business Administration or related field required.
• Three years of related experience required.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.