Senior Regulator Affairs Specialist Job Listing at Kelly Services in Bristol, TN (Job ID US3555717_BH9734588)

Description

Join a dynamic regulatory affairs team where you'll play a key role in compiling and reviewing FDA submissions, labeling, and change assessments for oral solid dosage pharmaceuticals. Leverage your regulatory expertise and project management skills to drive impactful, cross-functional initiatives in a fast-paced, compliance-driven environment.

Job Title: Senior Regulator Affairs Specialist
Location: Bristol-Kingsport, TN metro area (relocation assistance provided)
Salary: Commensurate with experience  

RESPONSIBILITIES:

1. Compilation/review of Annual Reports, original applications, amendments, and supplements and product labeling
2. Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents
3. Compilation and review of FDA Submissions (e.g., NDA/ANDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with change control review/approval and management.
    

KNOWLEDGE, SKILLS AND ABILITIES:

• Familiarity with oral solid dosage pharmaceuticals
• Competency with regulations, policies, and procedures relating to company and regulatory guidelines
• Ability to multitask and manage multiple projects with interdisciplinary teams
• Effective communication (verbal and written) with external and internal customers, vendors, and regulators
• Participation and familiarity with post-approval submissions to FDA, and with ad/promo materials to FDA as well as hands-on experience reviewing and approving labeling and marketing regulatory materials
• Strong planning and organizational / project / workload management skills
• Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
• Strong ability to work independently as well as in a team environment
• Ability to drive projects to completion with minimal guidance
• Solid interpersonal (verbal and written) communication skills at all levels
• Formal project management skills area plus
• Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus. Regulatory publication experience using eCTD software is a plus
• SAP experience a plus.
• Experience with metrics management and reporting.
• Proven negotiation skills with internal and external stakeholders.

 
QUALIFICATIONS:

• Bachelor's degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing).
• Minimum of 2 years of experience plus a Regulatory Affairs Certification (or) 4 years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment.

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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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