Regulatory Coordinator - Medix™ : Job Details

You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients. Job Summary Our client is seeking a Regulatory Coordinator responsible for performing duties associated with regulatory affairs and compliance requirements relevant to the OTC pharmaceutical industry. This salaried, exempt position will report to the Supervisor of Regulatory Affairs and is tasked with administering and maintaining various regulatory systems and processes to ensure compliance and support company objectives. Key Responsibilities

• Administer and maintain the company's Annual Product Review and generate reports.
• Support the administration and maintenance of the Company's Documentation Change Control System for compliance documentation.
• Monitor regulatory activities and proactively present, advise, and execute internal programs associated with these activities.
• Assist in maintaining master file documentation and databases.
• Administer adherence to procedural requirements in the development of Master Records.
• Support the development and implementation of regulatory strategies, approval schedules, and submission standards.
• Interface with Canadian and other international third-parties to ensure regulatory compliance.
• Support R&D staff in the compilation and submission of records for new product launches and market-specific registrations.
• Develop compliant Drug Facts Box information using FDA monographs and regulations.
• Maintain facility licenses and drug listings.
• Perform and assume other duties and responsibilities as required by the Supervisor.
• Support the Winner's Circle and Quality System processes.

Qualifications

• A 4-year technical college degree in a specialized field such as science or technology, or equivalent knowledge and training.

Experience

• 2 to 3 years of experience in a pharmaceutical regulatory environment.

Skills

• Attention to detail and ability to work well under pressure.
• Effective interpersonal skills for interacting with various levels of internal and external customers.
• Good oral and written communication skills in business English.
• Computer literacy in a Windows environment, including Word, Excel, and Outlook.
• Ability to prepare detailed and accurate documentation.
• Familiarity with FDA regulations and monograph system for OTC drug products.
• Working knowledge of Current Good Manufacturing Practices (cGMP).
• Strong organizational and analytical abilities.
• Ability to work independently and meet deadlines on concurrent tasks.
• Discretion with confidential information.
• Ability to develop and maintain effective working relationships with internal and external customers.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

* We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA). This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients. Medix Overview: With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we're dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.