Merakey Jobs

Regulatory Affairs Specialist – Onsite - Ottawa, Illinois

The Regulatory Affairs Specialist will ensure global compliance with all cosmetic and OTC regulatory requirements by performing a wide range of tasks. This role involves supporting and selectively managing regulatory affairs matters, collaborating with supervisors and key business partners to support global regulatory programs and strategies. Responsibilities include supporting new and existing products, process improvements, product registrations, and global market compliance. The specialist is responsible for implementing protocols, processes, and programs to maintain robust and compliant regulatory practices companywide.

Responsibilities:

• Collaborates with cross-functional project teams to complete regulatory-related assignments (such as Ingredient Lists, Quantitative Formulas, CCS) for both new and existing products, and clearly communicates requirements to colleagues.

• Ensures documentation related to regulatory matters, process and product/label changes are accurate and compliant.

• Works with supervisor to develop and communicate regulatory compliance requirements in support of New Product Development.

• Maintains regulatory files including claims support packages for new and existing products to ensure compliance and support/defend legal inquiries/challenges and regulatory audits.

• Works with supervisor to provide regulatory guidance with respect to short and long-term business planning.

• Monitors, interprets, makes recommendations to update product compositions, company procedures and documents with respect to forthcoming and/or changing state, US, and global regulatory requirements.

• Provides regulatory guidance/training as needed, ensuring compliance with all regulatory requirements in existing and new markets.

• Keeps Research and Development team updated of changing regulations and developing formulation guidelines.

Experience:

• Bachelor Degree and 2+ years in equivalent Regulatory Compliance Industry Experience (additional experience can substitute for degree requirements)

• Strong knowledge of cGMPs

• Hands-on experience with FDA regulations, Health Canada Regulation, EU regulations and guidelines.

• Hands-on, working knowledge of FDA OTC and cosmetic product regulations

• Experienced with label and claims review process

• Knowledge related to state based regulatory bodies and requirements (ex: Prop 65)

• Excellent oral and written skills

• Experience writing SDSs

• Open, honest communication skills

• Statistical Evaluation of data

• Understanding NGO requirements such as the Non-GMO project.

• Strong computer skills utilizing a Microsoft environment (Word, Excel, Access, Power Point)

• Reasoning Ability:

• Has the ability to define problems, collect data, establish facts, and draw valid conclusions in any situation

• Has the ability to solve problems and deal with a variety of variables in situations where only limited information exists.

Details:

• Direct Hire

• $70,000 - $90,000/year with Benefits

• Onsite in Ottawa, IL – relocation assistance negotiable

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.