Sr. Regulatory Compliance Specialist

🚀🌟 Exciting Opportunity: Sr. Regulatory Compliance Specialist (14450840) 🌟🚀

📍 Location: Somerset, NJ

👥 Position: 1

🗓️ Period: Approximately 3 months (Temp to Hire)

⏰ Shift: Monday to Friday, 8:30 AM - 5:00 PM

🤝 100% Onsite work

🚚 Relocation Required

Our client, a leader in the pharmaceutical industry, is seeking a Senior Regulatory Compliance Specialist to join their dynamic team in Somerset, NJ. If you’re looking to make an impact in a fast-paced, global environment 🌍 and contribute to high-visibility projects, this could be the perfect opportunity for you! 🌟✨

As a Senior Regulatory Compliance Specialist, you’ll play a critical role in ensuring compliance with global regulations ✅, working closely with various teams such as Supplier Quality, Regulatory Compliance, DEA, and QMS. This position requires a proactive, self-motivated individual who is comfortable navigating complex regulatory environments ⚖️ and driving results. 🎯

💼 Key Responsibilities:

• 📋 Manage the Supplier Quality Program, ensuring deliverables are met.
• 📝 Facilitate and host customer audits to ensure compliance with cGMPs and corporate SOPs.
• 🔍 Lead internal audits and assist in preparing the site for inspections by the US FDA 🇺🇸 and other international regulatory authorities 🌎.
• 🚀 Ensure the site’s audit readiness for new product approvals.
• 🤝 Develop and review Quality Agreements with suppliers and customers.
• 👩‍💼 Act as the QA Representative, reviewing and approving TrackWise records.
• ✍️ Prepare written responses to audit observations and regulatory inspections, ensuring timely completion ⏳.
• 🛠️ Support PAI audits, compiling and reviewing documents to ensure full compliance.

📋 Qualifications:

• 🎓 Bachelor’s degree with 5+ years of experience in Regulatory Compliance, Quality Assurance, or a related function in the pharmaceutical industry.
• 📜 OR an Associate degree or High School Diploma with 10+ years of relevant experience.
• ✅ Strong knowledge of US FDA regulatory requirements, particularly in solid oral dosage forms or similar regulated industries.
• 💻 Experience with TrackWise is a plus, as well as certifications such as ASQ CQA 🏅.

Why This Role?

This is a high-impact position 🎯 within a renowned pharmaceutical company that offers the opportunity to lead key compliance initiatives. You’ll be part of a team 💼 that plays a pivotal role in regulatory processes, working with both US and international health authorities 🌍.

If you’re detail-oriented, thrive under pressure 💪, and are looking for a long-term career opportunity 🚀, we want to hear from you! ✨

📧 Apply Today! Send your updated resume to careers@proqualitynet.com or apply directly through this job post. 📨