Regulatory Affairs Specialist 2

Job# : 2050876

Job Description :

Job Title : Regulatory Affairs Specialist 2

Pay Range : $21-$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). They will a meeting once a week in the morning meetings 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, looking at ingredient list is accurate.

Look at products in profile. 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 Bachelors degree. (preferred in a related field with 2-4 years experience)
• Experience in personal care products, a few years of work experience, background in science related field (preferred - , Chemistry).
• Knowledge with FDA, up to speed with regulations on laws to abide by.
• Proficient in MS.
• VMS - SAP experience ( highly preferred)

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 will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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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.

Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.