Senior Regulatory and Compliance Specialist

Ardena • Franklin Township, NJ

113d • $100,000 - $120,000

About The Position

As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support. With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team. We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us. If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.

Requirements

• A bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related functions.
• Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function.
• Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required.
• Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required.
• Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred.
• Demonstrated experience with customer and internal audits is preferred.
• Demonstrated experience with Health Authority Inspections (front or back room) is highly preferred.
• Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent.

Responsibilities

• Facilitate and host customer audits at the Somerset site to ensure compliance with cGMP’s, as well as international regulatory compliance and site standard operating procedures.
• Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations.
• Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Participate in all aspects of inspections from initiation, preparation, execution through closure.
• Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensure audit readiness.
• Review and approve Quality Management System Records as needed acting as a QA Representative.

Benefits

• A competitive salary with a tailor-made benefits package, including: medical, dental and vision benefits effective day one of employment.
• Paid Time Off.
• Salary Range: $100,000.00-$120,000.00.
• A dynamic, global work environment with career growth opportunities.
• Access to Ardena Academy, our internal learning platform for professional development.
• A chance to contribute to groundbreaking drug development projects that make a real impact.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree