Apex Systems is looking to hire FULLY REMOTE Regulatory Affairs Specialists!
For immediate consideration please send an updated copy of your resume to Megan at mmantlo@apexsystems.com with "Remote Regulatory Affairs Specialist" in the subject line.
Job Title: Regulatory Affairs Specialist 2
Pay Range: $21/hr - $26/hr
Location: Fully Remote (Must be able to work EST hours)
Duration: 12 month contract
Shift: Any time zone, just be available during core hours (EST). There will be a meeting once a week in the morning at 8am EST (5am PST).
Summary:
The main function of a regulatory affairs specialist is to implement policies and coordinate community affairs strategies. A typical regulatory affairs specialist will develop and maintain supportive relationships with regulatory bodies.
Job:
Helping with major projects - One of them is a project to look at artwork and labeling, ensuring the ingredient list is accurate, and reviewing raw materials and ingredients lists.
Responsibilities:
* Compile and maintain regulatory documentation databases or systems.
* Coordinate efforts associated with the preparation of regulatory documents or submissions.
* Analyze product complaints and make recommendations regarding their reportability.
* Develop or conduct employee regulatory training.
* Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
* Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
* Coordinate, prepare, or review regulatory submissions for domestic or international projects.
* Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Qualifications:
* Must have a Bachelor's degree (preferred in a related field with 2-4 years experience).
* Experience in personal care products, with a background in a science-related field (preferred - i.e., Chemistry).
* Knowledge of FDA regulations and compliance.
* Proficient in Microsoft Office.
* VMS - SAP experience (highly preferred).
Job#: 2050876
EEO Employer:
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.
#J-18808-Ljbffr