regulatory affairs coordinator.

job summary:
Regulatory Affairs Coordinator

JOB SUMMARY

The Regulatory Affairs Coordinator is responsible for performing duties associated with regulatory affairs and compliance requirements relevant to the OTC pharmaceutical industry

 
location: Oak Brook, Illinois
job type: Temporary
salary: $27 - 30 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
ESSENTIAL JOB FUNCTIONS

1. Administers and maintains the Company's Annual Product Review including generating the reports.
2. Supports administering and maintaining the Company's Documentation Change Control System for compliance documentation.
3. 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.
4. Assists in maintaining product and raw material master file documentation and databases.
5. Administers the adherence to procedural requirements in the development of Master Records.
6. Proficient at reading, reviewing and auditing documents and following procedures.
7. Ability to understand the importance and the elements of a good change control process and understand compliance product lifecycles.
8. Administer and maintain the Company's Annual Product Review process and reporting generation.
9. Master the understanding of the cGMP requirements associated with the production and Quality life-cycle of an OTC drug.
10. Solid understanding of technical requirements for all quality and regulatory documentation supporting batch production documents and their lifecycle.
11. Ability to understand and interpret product regulatory requirements from FDA OTC monograph, US Pharmacopeia and/or others, local, state, federal and international regulatory agencies.
12. Ability to monitor regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and understand their impact to the Company.

ADDITIONAL RESPONSIBILITIES

1. Supports the development and implementation of regulatory strategies, approval schedules, and submission standards to achieve department and organization objectives.
2. Interfaces with Canadian and other international third-parties to ensure regulatory compliance.
3. Interfaces with R&D staff and provides support in the compilation and submission of records for new product launches and market-specific registrations.
4. 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.
5. Maintains facility licenses and drug listings.
6. Performs and assumes other duties and responsibilities, as may be required by the Supervisor, Regulatory Affairs.
7. Firm understanding of the organization QMS in order to properly manage the review and approval of all company cGMP documentation and APR creation.
8. Able to summarize technical compliance documents and provide recommendations.
9. Clear understanding of the documents necessary to support a complete product master file and raw material master file.
10. Working understanding of the Company Stability program and its impact on product lifecycle.
11. Firm understanding of the departmental compliance role and responsibilities.

 
qualifications:
REQUIRED EDUCATION, EXPERIENCE AND SKILLS

1. 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.
2. Attention to detail and ability to work well under pressure.
3. Capable of managing tactical steps to push tasks forward.
4. Effective interpersonal skills to interact with various levels of internal and external customers.
5. Must demonstrate effective communication skills (both written and oral) for interactions with Quality colleagues, and colleagues from numerous functional areas.
6. Good oral and written communication skills in business English (spelling, grammar, and punctuation).
7. Computer literacy in a Windows environment (Word, Excel, and Outlook).
8. Ability to prepare detailed and accurate documentation.
9. Familiarity with FDA regulations and monograph system as they relate to OTC drug products.
10. Working knowledge of Current Good Manufacturing Practices (cGMP).
11. Strong organizational and analytical abilities.
12. Ability to work independently and meet deadlines on a multitude of concurrent tasks.
13. Willingness to accept other duties, as assigned.
14. Discretion with confidential information.
15. Must listen actively and readily assumes responsibility for actions.
16. 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.

PHYSICAL DEMANDS & ENVIRONMENT

1. This position requires the individual to Stand, Walk, use hands to finger, handle or feel, climb or balance, stoop, kneel, bend or crawl, reach with hands and arms overhead up to 33% of the time. This position requires the individual to Sit, Talk or Listen 66 to 100% of the time.
2. This position will require the individual to lift up to 25 pounds 33 to 66% of the time.
3. The vision requirements for this position includes Close Vision (clear vision at 20 inches or less), Distance Vision (clear vision of 20 feet or more), Color Vision (ability to identify and distinguish colors), Peripheral Vision (ability to see up, down, left or right while eyes are fixed on a given point), Depth Perception (3-dimensional vision, ability to judge distances and spatial relationships), and Ability to Adjust Focus (ability to adjust the eye to bring an object into sharp focus).
4. The noise level for this position will be Moderate Noise (Ex: Business office with typewriters and/or computer printers, light foot traffic).
5. The Personal Protective Equipment requirements that are used in this position is a hair net, beard net and safety glasses.

 
skills: Regulatory Affairs Operations


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