Regulatory Affairs Coordinator

Job Description

Job Description

Job Posting : Regulatory Affairs Coordinator

Location : Oak Brook, IL - on-site position

Schedule : 1st Shift : Monday - Friday | 8 AM – 4 : 15 PM

Status : Salaried, Exempt

About the Role :

The Regulatory Affairs Coordinator is responsible for performing duties associated with compliance requirements relevant to the OTC / pharmaceutical requirements for all Blistex Inc. products. This role will administer and maintain the Company’s Documentation Change Control System and should therefore be highly proficient at reading, reviewing and auditing documents, and following procedures. They will possess a strong ability to summarize technical compliance documents and provide recommendations.

Key Job Responsibilities

• This position administers, maintains, and generates reports for the Company’s Annual Product Review.
• Supports administering and maintaining the Company’s Documentation Change Control System for compliance documentation.
• Supports the development and implementation of regulatory strategies, approval schedules, and submission standards to achieve department and organization objectives.
• 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.
• Assists in maintaining product and raw material master file documentation and databases.
• Adheres to all procedural requirements in the development of Master Records.
• Interfaces with Canadian and other international third parties to ensure Blistex regulatory compliance.
• Collaborates with R&D staff and provides support in the compilation and submission of records for new product launches and market-specific registrations.
• 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.
• Maintains facility licenses and drug listings.

Basic Qualifications

Additional Qualifications

Diverse Experiences

Blistex is committed to a diverse and inclusive workforce. Blistex is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age or any other legally protected status.

Career Growth

Were continuously raising our performance bar as we strive to become the best in our industry. You will find endless knowledge-sharing, mentorship, career opportunities and development opportunities to help you become a better professional and / or leader.

Compensation

The base pay for this position ranges from $70,000 to $73,000 annual salary. Pay is based on a number of factors including job related knowledge, skills and experience. The job role is eligible for a nondiscretionary bonus that may be provided as part of a total compensation package.

Benefits

As part of the total compensation package a full range of benefits are offered including medical coverage, insurance, and financial benefits. For more information, please visit https : / / blistexinc.com / employee -benefits / .