Regulatory Affairs Specialist 2 - 2050876

$43,680 - $54,080/Yr

ASGN - Shelton, CT

Full-time - Entry Level

Remote - Shelton, CT

Administrative and Support Services

About the position

The Regulatory Affairs Specialist 2 is responsible for implementing policies and coordinating community affairs strategies, focusing on maintaining supportive relationships with regulatory bodies. This role involves assisting with major projects, particularly in reviewing product labeling and ingredient accuracy, and ensuring compliance with regulatory standards.

Responsibilities

• Compile and maintain regulatory documentation databases or systems.
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Analyze product complaints and make recommendations regarding their reportability.
• Develop or conduct employee regulatory training.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

Requirements

• Bachelor's degree (preferred in a related field) with 2-4 years of experience.
• Experience in personal care products and a background in a science-related field (preferred - e.g., Chemistry).
• Knowledge of FDA regulations and compliance requirements.
• Proficient in MS Office; experience with VMS and SAP is highly preferred.

Benefits

• Comprehensive benefits package including quality career resources, training, certifications, and development opportunities.