Job Description

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

• Bachelor’s degree in chemistry, biology, or related scientific discipline with 2-3 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry; or 0-1 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.
• Must demonstrate effective communication skills (both written and oral) for interactions with Quality colleagues, and colleagues from numerous functional areas.
• Computer literacy in a Windows environment (Word, Excel, and Outlook).
• Familiarity with FDA regulations and monograph system as they relate to OTC drug products.
• Working knowledge of Current Good Manufacturing Practices (cGMP) especially as related to the production and Quality lifecycle of an OTC drug.
• Strong organizational and analytical abilities and abilities to prepare detailed and accurate documentation.
• Strong discretion with confidential information.
• Ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management, and comply with Company policies.
• Ability to understand the importance and the elements of a good change control process and understand compliance product lifecycles.
• Solid understanding of technical requirements for all quality and regulatory documentation supporting batch production documents and their lifecycle.
• Ability to understand and interpret product regulatory requirements from FDA OTC monograph, US Pharmacopeia and/or others, local, state, federal and international regulatory agencies.

Additional Qualifications

• Working understanding of the Company Stability program and its impact on product lifecycle.
• Firm understanding of the departmental compliance role and responsibilities.
• Strong ability to plan, organize, and complete concurrent tactical tasks and strategic departmental tasks independently.
• Clear understanding of the documents necessary to support a complete product master file and raw material master file.
• Willingness to perform and assume other duties and responsibilities, as may be required by the Senior Manager, Regulatory Affairs.

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 -benefits/.

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