Senior Associate, Regulatory Affairs Job Listing at Kelly Services in Bristol, TN (Job ID US3539970_BH9734588)

Description

Job Title: Senior Associate, Regulatory Affairs
Location: Bristol, Tennessee (100% on-site and relocation assistance provided)
Salary: $90-105,000 dependent upon experience 
 

POSITION SUMMARY:
Responsible for support of regulatory affairs activities under direction of department management. Activities may include but are not limited to: Compilation/review of Annual Reports, original applications, amendments, and supplements and product labeling.
Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents.
 

ROLES & RESPONSIBILITIES:
Product support activities: 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.
 

QUALIFICATIONS:

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

 

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.
• Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat,
• including database management and support. SAP experience a plus.
• Experience with metrics management and reporting.
• Proven negotiation skills with internal and external stakeholders.

 

TRAVEL REQUIREMENTS & WORKING CONDITIONS:

• May require occasional travel as needed
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of office work
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or inspect; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell
• The employee may infrequently lift or move up to 30 pounds
• Job requires close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus

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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