Job Title: USA-Regulatory Affairs Specialist II (Clinical)
Location: Swiftwater, PA, USA
Join our dynamic team as a Regulatory Affairs Specialist II (Clinical). This is a hybrid role, perfect for individuals with a background in Bioscience or Engineering. You’ll be working in a team environment, collaborating with scientists, marketing, and supply chain professionals. Your role will involve supporting manufacturing and supply, ensuring regulatory requirements are met, and updating product dossiers.
Job Responsibilities:
- Support manufacturing and supply to ensure regulatory requirements are met
- Update product dossiers and author regulatory changes
- Interpret technical documents and results
- Maintain regulatory compliance for License registrations
- Manage regulatory activities linked to change controls for the site
- Act as a regulatory expert for regulatory topics and projects at our client’s location
Skills Required:
- Strong technical authoring skills
- Proficiency in MS Word, Excel, and MS Suite
- Experience with Vault Rim system or similar quality documentation and regulatory submission systems
- Ability to work in a team environment and communicate effectively via email
- Ability to quickly adapt and learn new tasks
- Bachelor’s degree in pharma, bio, or engineering (Master’s degree preferred)
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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