Regulatory Affairs Manager (Remote/Hybrid) Job Listing at Kelly Services in Venice, FL (Job ID 9321090)

Description

Regulatory Affairs Manager

Hybrid/Remote with up to 10-20% travel on site as needed
Monday-Friday 8am-5pm, some hours outside of this time frame
 

Position Overview: As the Regulatory Affairs Manager, you will collaborate closely with the leadership team to ensure compliance with applicable regulations and standards governing the manufacturing, labeling, marketing, and distribution of our products. Your primary focus will be on developing and implementing regulatory strategies to achieve successful and expedient product compliance and registrations worldwide.

Key Responsibilities:

1. Regulatory Compliance:

   • Monitor and interpret federal, state, and international regulations relevant to the dietary supplement industry, including FDA regulations, DSHEA (Dietary Supplement Health and Education Act), GMP (Good Manufacturing Practices), GFSI, and labeling requirements.

2. Strategic Planning:

   • Lead the development of regulatory strategies and implementation plans to ensure global compliance for new projects, product developments, and line extensions.

3. Knowledge Management:

   • Stay informed about FDA, GFSI, and international regulations, guidance, and standards applicable to our products.
   • Provide technical leadership and vision by interpreting emerging national and international regulatory trends.

4. Documentation and Submissions:

   • Create and maintain comprehensive documentation related to regulatory compliance activities, including regulatory submissions, certifications, and correspondence with regulatory agencies.

5. Product Registration:

   • Facilitate product registrations and certifications to support sales teams in increasing distribution in the USA and international markets.
   • Collaborate with Sales teams to provide detailed formula information for private label opportunities.

6. Quality Assurance Collaboration:

   • Collaborate with quality assurance teams to ensure adherence to regulatory standards throughout all stages of product development, manufacturing, and distribution.
   • Participate in staff training on DSHEA compliance, cGMP, and SQF.

Qualifications:

• Bachelor's degree in Regulatory Affairs, Chemistry, Biology, or a related field.
• Proven experience in regulatory affairs within the dietary supplement or related industry.
• In-depth knowledge of FDA regulations, DSHEA, GMP, and GFSI.
• Strong organizational and project management skills.
• Excellent communication and collaboration abilities.

 

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.

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