Sr Scientist, Regulatory Affairs Job Listing at Kelly Services in Clark, NJ (Job ID 9546158)

Description

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer an opportunity to work as a Sr Scientist, Regulatory Affairs located in Clark, NJ.

Duration: 9-12month contract with the potential to extend or go perm.
Schedule: Monday-Friday, 8A-5P
Location: Clark, NJ (ideal if candidate is willing to travel hybrid between Clark NJ and NYC)
Compensation: $50-60/hr


Purpose of the Role:                                                                                                    

1. Administer regulatory affairs over the product lifecycle from pre-market concept, product development, registration
2. Actively support regional regulatory affairs teams and documentation requirements.
3. Support risk management, regulatory intelligence and continual improvement projects.

Responsibilities:
Regulatory Compliance:

1. Review formulations to ensure compliance of finish products with global regulatory standards
2. Provide advice to labs and product development teams and give guidance on potential regulatory compliance issues
3. Respond to inquiries regarding ingredients, formulations, regulatory issues and associated requirements.
4. Prepare and review of regulatory compliance documents for product registration
5. Register products according to regulatory requirements/ Support regulatory reporting and registration requirements
6. Regularly update registration database and advise key stakeholders of the progress of registrations.
7. Keep abreast of regulatory changes in our markets, assessing and communicating impact to the Regulatory Affairs team and other internal stakeholders / Monitor new regulations, evaluate impact to the business and lead on next steps
8. Support Risk identification, reduction, mitigation and escalation processes
9. Manage regional projects and be able to collaborate with countries and to set up priorities
10. Accurately compile and procure notarised documentation, such as Certificates of Free Sale

Others:

1. Support and maintain Regulatory procedures/position statements.
2. Support other activities (artwork, post-market advertising compliance and vigilance activities)
3. Support Regulatory Department Improvement Projects

Qualifications:
Technical Requirements:

1. Degree in Science (Pharmaceutical Science, Pharmacy, Health Science, Food Science, Nutrition, Chemistry – highly regarded)
2. Application and understanding of MoCRa
3. Application and understanding of FDA regulations

Key Experience, Knowledge & Skills Required:

1. 3-5 years' experience in regulatory and/or product safety in cosmetics, personal care, chemical or dietary supplement industries
2. Demonstrated experience interpreting FDA regulations for drug products and for cosmetics MoCRa,
3. Developed experience in regulatory artwork copy briefing and proofing.
4. Developed communication and presentation skills.
5. Ability to navigate ambiguity, manage stakeholders in fast paced environments.
6. Critical thinking and keen attention to detail.
7. Strong time management and organisational skills.
8. The ability to be onsite, in the office as this is an essential function of the position (required)
   Authorization to work in the United States on a full-time, permanent, ongoing basis without the need for legal sponsorship now or in the future (required)

P#1
Send resumes to Jacqueline.Sayoc@KellyScientific.com
 

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 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.

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