Regulatory & Documentation Specialist

Blistex Inc.; Oak Brook (IL); On-site; USD 80,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Insurance benefits

Bonus potential

Job summary

Blistex Inc. in Oak Brook, IL is seeking a Regulatory & Documentation Specialist to oversee regulatory affairs and compliance for OTC products under FDA guidelines. The role focuses on maintaining change control, labeling reviews, and compiling Drug Facts Box information.

You will coordinate with R&D, QA, and international partners, prepare registration dossiers, and support audits and submissions to meet global regulatory standards. A strong background in cGMP and documentation is essential.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related scientific discipline with QA experience.
• Master's degree in Regulatory/Quality with related QA or regulatory experience.
• Demonstrates high standards of ethics and compliance; creates culture of trust.
• Excellent written and oral communication in business English.

Responsibilities

• Administers and maintains the Change Control System for compliance documentation.
• Reviews and evaluates product labeling for regulatory compliance.
• Develops Drug Facts Box information per FDA monographs and regulations.
• Develops country-specific ingredient lists using international guidance.
• Maintains facility licenses and drug listings; supports master records documentation.

Skills

Attention to detail

Analytical thinking

Effective communication

Regulatory knowledge

FDA regulations

Document control

Quality Assurance

Education

Bachelor's in Chemistry/Biology/related

Master's in Regulatory/Quality

Tools

MS Word

MS Excel

MS Outlook

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regulatory & Documentation Specialist

Regular Full-Time Oak Brook, IL, US

2 days ago Requisition ID: 1427

Salary Range: $80,000.00 To $86,000.00 Annually

Job Posting: Regulatory & Documentation Specialist

Location: Oak Brook, IL

About the Role:

The Regulatory & Documentation Specialist is responsible for performing duties associated with regulatory affairs and compliance requirements relevant to the OTC pharmaceutical industry and Blistex Inc. Using knowledge of FDA and other regulations, the Specialist ensures that all documentation is in adherence with compliance standards for all Blistex Inc. products.

Key Job Responsibilities

• Administers and maintains the Company’s Change Control System for compliance documentation.
• Reviews and evaluates product labeling to ensure compliance with all regulations and requirements.
• 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.
• Uses guidance from international third-parties to develop country-specific formula ingredient lists.
• 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.
• Maintains facility licenses and drug listings.
• Administers the adherence to procedural requirements in the development of Master Records.
• Reviews and approves specifications (labeling, raw materials, packaging, product certificates of analysis, etc.).
• Prepares dossiers and supports the registration of Canadian and other international products.
• Acts as the principal department contact for handling, planning, and responding to regulatory questions and requests.
• Develops and implements creative regulatory strategies, approval schedules, and submission standards to achieve department and organization objectives.
• Interfaces with Canadian and other international third-parties to ensure Blistex regulatory compliance.
• Interfaces with R&D staff and provides support in the compilation and submission of records for new product launches.
• Participates in facility audits and on issue-specific committees, as required by the Manager, Regulatory Affairs.
• Performs and assumes other duties and responsibilities, as may be required by the Manager, Regulatory Affairs.

Basic Qualifications

• Bachelor's degree in Chemistry, Biology, or related scientific discipline with 3-5 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry or 1-2 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.
• Master's degree in Regulatory/Quality, or related scientific discipline with 1-3 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry or 1-2 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.
• Demonstrates high standards of ethics and compliance. Creates culture of mutual trust and understanding.
• Attention to detail and ability to work well under pressure.
• Effective interpersonal skills to interact with various levels of internal and external customers.
• Proficient at effective communication skills (both written and oral) for interactions with Quality colleagues, project managers, and colleagues from numerous functional areas.
• Good oral and written communication skills in business English (spelling, grammar, and punctuation).
• Computer literacy in a Windows environment (Word, Excel, and Outlook).
• Ability to prepare detailed and accurate documentation.
• Able to present complicated compliance issues in a variety of business settings.
• Familiarity with FDA regulations and monograph system as they relate to OTC drug products.
• Working knowledge of Current Good Manufacturing Practices (cGMP).
• Strong organizational and analytical abilities.

Additional Qualifications

• Ability to work independently and meet deadlines on a multitude of concurrent tasks.
• Discretion with confidential information.
• Proficient at listening actively and readily assumes responsibility for actions and leads by example.
• Proficient at managing tactical steps to push tasks forward.
• 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.
• Master the ability of reading, reviewing and auditing documents and following procedures. Proficient at understanding the importance and the elements of a good change control process.

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.

We’re 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 $80,000 to 86,000. Pay is based on a number of factors including job related knowledge, skills and experience. The job role is eligible for a discretionary bonus that may be provided as part of a total compensation package.

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/ .