Regulatory Affairs Generalist - Hybrid (Bridgewater, NJ)

Orbis Clinical is seeking a Regulatory Affairs Generalist located in Bridgewater, NJ (Hybrid) for a long-term contract opportunity through the end of 2027.

Job Title: Regulatory Affairs Generalist

Location: Hybrid (Bridgewater, NJ)

Contract: Long-term contract opportunity through the end of 2027

Summary:

Seeking a Regulatory Affairs Generalist for a contract opportunity supporting our client in Bridgewater NJ in the life sciences industry. If you’re experienced in preparing FDA submission materials, committed to accuracy and regulatory compliance, and thrive in a fast-paced, professional environment, trust The Experts at Hiring Experts to guide your next career move.

Typical day as Regulatory Affairs Generalist:

• Reviewing, proofreading, and quality-checking FDA submission components for IND, NDA, and ANDA products
• Authoring and supporting regulatory documentation, including cover letters, FDA forms, Module 1 documents, annual reports, labeling, non-CMC supplements, and product correspondence
• Preparing and reviewing modular submission content from nonclinical, clinical, and medical affairs subject matter experts
• Collaborating with Regulatory Management to ensure product documentation aligns with regulatory requirements
• Supporting preparation of materials for regulatory authority interactions
• Delivering final submission-ready documents for e-publishing and eCTD format submission
• Communicating progress, potential risks, and regulatory concerns to Regulatory Product Leads and/or Regulatory Affairs leadership
• Contributing to special projects and continuous process-improvement initiatives as assigned

This job might be an outstanding fit if you:

• Have at least an Associate degree; Bachelor’s degree is preferred or equivalent relevant experience
• Possess a minimum of 1.5 years of Regulatory Affairs experience or experience in a regulated environment
• Demonstrate working knowledge of pharmaceutical Regulatory Affairs across development, labeling, and post-market activities
• Are familiar with domestic and international regulatory laws, regulations, and guidance
• Understand clinical development and regulatory requirements for development milestones and market authorization
• Are proficient with Microsoft Word, Excel, Adobe Acrobat Pro, eCTD submission-format requirements, and controlled document management systems (Documentum experience preferred)
• Have excellent attention to detail, proofreading, analytical reasoning, and critical-thinking skills
• Communicate clearly both in writing and verbally, and collaborate effectively across teams
• Can assess project risks, escalate concerns appropriately, and respond decisively in changing circumstances

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $35.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.