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Regulatory Affairs Generalist
Bridgewater, NJ, US
Scientific
Associate Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Bridgewater, NJ, US
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Associate Degree
First Shift (Day)
Job details
Regulatory Affairs Generalist
Kelly Science and Clinical is seeking a Regulatory Affairs Generalist for our client a leading medical device company in Bridgewater, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Schedule: HYBRID 3 days on site 2 days remote
Shift: Monday through Friday day shift
Length of assignment: Until the end of 2025
Pay: $37-$40 an hour
Key Responsibilities
- Responsible for reviewing, proofreading, and quality checking components of FDA submissions, ensuring accuracy for IND/NDA/ANDA products.
- Proficient in WORD, EXCEL, Adobe Acrobat Pro, eCTD format requirements, and Controlled Document Management System (preferably Documentum).
- Engage in regulatory writing with a clear understanding of contributions from subject matter experts in nonclinical, clinical, and medical affairs.
- Provide operational and administrative regulatory writing (cover letters, FDA forms, and other Module 1 documents) and support content preparation and review for INDs, NDAs, and ANDAs, including annual reports and labeling.
- Collaborate with Regulatory Management to ensure documentation meets regulatory requirements, serving as a designee when needed.
- Support the preparation of documentation and materials required for interactions with Regulatory Authorities.
- Deliver final documents to regulatory operations for e-publishing and submission in eCTD format.
- Communicate directly with and support Regulatory Product Leads and/or Director on assigned tasks.
- Advise Regulatory Product Leads and/or Director on any delays or potential regulatory issues.
- Undertake other project-based tasks and special projects as assigned by Regulatory Management.
- Competencies and Skills
- Demonstrated analytical reasoning and critical thinking skills.
- Strong team collaboration abilities.
- Excellent written and oral communication skills.
- Strong interpersonal skills to influence positively and effectively.
- Continuous learning mindset and process improvement contribution.
- Quick and decisive reaction capability in unexpected situations.
- Detail-oriented with proficiency in proofreading for accuracy and inconsistencies.
- Comprehensive knowledge of pharmaceutical regulatory affairs, including Development, Labeling, and post-market requirements.
- Understanding of domestic and international regulatory laws, regulations, and guidance.
- Familiarity with clinical development and management of development milestones and market authorization.
- Ability to assess and escalate project risks appropriately.
Qualifications
- Minimum Associate degree, Bachelor’s degree preferred or equivalent.
- Minimum of 1.5 years of Regulatory Affairs experience or relevant experience in a regulated environment.
What happens next
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about,
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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.