Regulatory Affairs Specialist Job Listing at Kelly Services in Beloit, WI (Job ID 9402806)

Description

Kelly is seeking qualified candidates for a Regulatory Affairs Specialist to work at one of top clients in Beloit, WI.

• Pay: $30/hr - $40/hr depending on experience & education
• Assignment Duration: 6.5 months
• Shift/Hours: Day shift
• Able to work remotely

Overview / Accountability
The role of the Scientist is to support the Pillar function for the core product foundational technology and global market clearance strategy. The Scientist will support the Senior/Principle Scientist in addressing more complex regulatory related topics. The Scientist will also be the primary contact for supporting GBS centers with complex customer questions regarding the core products as well as draft relevant statements for review by Sr. Scientist to support commercialization. The Scientist will play a supporting role providing data input for internal ICT systems used to maintain product data.


Key Responsibilities

• Commercialization- Maintains relevant databases and processes change requests to support commercialization of core products (Optiva GT).
• Strategic Business Partner- Support Sr/Principle Scientist with submissions to International Health Authorities. Works with the Product management, Marketing and Business development teams to support the regulatory strategy for success of the project/development. Research ingredient review approval and use status for the application and country requested; manages these strategies and consultant work as needed.
• Innovation & Ideation- Support the R&D team of scientists to provide regulatory expertise and advisement on ingredients (are they approved for use in application), on claims, and certifications throughout the development team process. Keep abreast of the latest development of relevant industry regulations and regulatory trends across the region and share with relevant stakeholders.
• Internal stakeholders-Manage emerging issues and be a first point of contact for GBS escalations. Support stakeholders in the development of customer presentations. Provides general technical support for other departments including research, problem solving, identification of experts, response to inquiries, and technical summaries.
• All other duties as assigned.
   

Leadership Competencies
Competency How it's demonstrated : H/M/L
Role modelling

• Leads by example.
• Acts in a that is both trustworthy and trusting, champions the values of the organization and challenges unacceptable behaviors.
• Displays passion for one company idea and seeks opportunities to maximize value from it.
• Shares knowledge and recognizes success.

Vision & Strategic Thinking (L)

• Displays confidence, energizes and inspires others.
• Develops strategies for growth.

Leading and Managing Change (M)

• Demonstrates an ability to identify and drive continuous improvement initiatives.
• Demonstrates the flexibility and adaptability to be successful in a changing environment.
• Embraces new ideas and approaches.

Customer Engagement & Relationships (M)

• Inspires confidence in our customers.
• Builds relationships with customers at all levels.
• Positively & constructively engages customers to defend/ win business.

People & Self Development (L)

• Seeks feedback, is open to ideas of others.

Matrix Management/ Business Connect (M)

• Actively engages across the organization.
• Builds partnerships based on trust and integrity.
• Engages effectively across business, functional and geographic boundaries.
• Collaborates to maximize value from cross functional working.

Technical Competencies
Competency How it's demonstrated : H/M/L
Technologies & EUM Applications (M)

• Knowledgeable about technologies within a specific expertise in a chosen area. Good scientific and technical knowledge. General knowledge of food drug regulations. Participates in regulatory related business projects as appropriate. Ability to make recommendations to senior management in the businesses on regulation changes.

Technical Expertise (H)

• Fundamental scientific background, with focus on Food or Drug safety.
• Working knowledge of Chemistry/microbiological controls associated with manufacturing food and drug products
• Entry level knowledge about toxicology studies used to support safety narratives and assessments
• Working knowledge of regulations around product labelling marketing and advertising
  Key Competencies (H)
  • Strong troubleshooting and root cause analysis skills.
  • Project Management Expertise.
  • Competency in the cluster technology.
  Critical Thinking & Influence (H) • Proactively partner with RDA, EUM & Commercial colleagues to inform on regulatory activities that may impact the business and Pillar strategic priorities
  • Proactively partner with Marketing and R&D teams on new product development, claims, novel ingredients, new regulations, to ensure compliance with regulations & informing appropriate marketing communications and customer relationships.

Organizational Understanding (H)

• Understands the overall business objectives and customer expectations.
• Views Food Safety and Quality as a distinguishing capability and business imperative. Dove tails Food Safety and Quality with the overall business objectives for a pragmatic approach.
   

Specific Skill Requirements
Essential Desirable

• Education: BSc in Chemistry/Biochemistry/Toxicology or equivalent as minimum. Additional qualifications are advantageous such as an Advanced degree.

Technical

• 3+ years' experience in regulatory/technical role in food or drug industry

Behavioral

• Good oral and written communication skills through different levels in the organization.
• Ability to search for regulatory changes in the regulatory landscape that may impact the business to present to senior management.
• Good presentation and interpersonal skills develop and implement projects, work with direction, report results in a conscience manner.
• Problem solver, solution seeker, contribute workable creative ideas, interact with other groups within the company and when necessary, with external stakeholders.

Direct Reports: None May review work of technologist level.

#P2
 

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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