Regulatory Specialist - Pharmaceutical GMP
Category: Scientific & Clinical
Job ID: 279338
Date Posted: 01/25/2023
Start Date: 01/04/2023
Title: Regulatory Specialist
Location: Allendale, NJ area
Duration: Direct Hire
Schedule: M-F Full Time
Target Start: ASAP
- Work with internal departments, external business partners, and clients, as it relates to regulatory requirements.
- Prepare and file submissions, updates, annual reports, and other documents to FDA.
- Establish and maintain electronic system for submitting documentation to FDA through Gateway.
- Interact as needed with FDA or other health authorities. Prepare and provide necessary documentation.
- Supporting the QA department assisting with QA activities including investigations, batch record review, and auditing.
Provide regulatory guidance and oversight, including interpretation of guidances and suggestions for how to implement.
- Degree in Chemistry, Pharmacy, or related discipline
- Experience in the Pharmaceutical Industry and experience working in Regulatory Affairs.
- Quality Assurance experience or working closely with GMP Quality teams.
- Pharmaceutical and Contract Manufacturing Organization experience desired.
- Knowledge of cGMPs and FDA guidelines required.
- Must be well organized, detail-oriented, and capable of handling regulatory activities independently.
- Have solid understanding of FDA regulations.
- Must be a team player, able to make recommendations, and meet deadlines.
- Strong computer skills are a necessity, with an ability to accurately convey information in both spoken and written form.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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