Regulatory Site Support

Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.

Your work is crucial to the success of these projects.

Responsibilities

• As a Regulatory Site Support you are responsible for supporting regulatory compliance for both clinical and marketed products by ensuring correct and timely handling of all regulatory CMC activities.
• You ensure that CMC dossiers are and remain aligned with implemented manufacturing and control procedures on site.
• You act as a regulatory expert within project teams, providing accurate intelligence to align proposals with current regulatory guidelines and Health Authority expectations worldwide.
• You review and approve GMP site documents.
• You assess the regulatory impact of proposed changes and manage their implications within Change Control and Deviations.
• You provide regulatory information for deviations to assess compliance impact.
• You act as the site’s regulatory interface with Global Regulatory Affairs and external partners.
• You write and/or author CMC regulatory documents/dossiers and supporting documents for clinical applications, marketing authorizations, and post-approval changes globally.
• You maintain Product Licenses and support new registrations, including renewals, annual Product Reports, site registrations, and transfers.
• You identify early the documentation required for regulatory submissions and potential issues with content, quality, or timely delivery.
• You negotiate timely delivery of high-quality technical source documents in line with project timelines.
• You respond to Information Requests or deficiency letters from Health Authorities promptly, for both CMC dossier- and inspection-related queries.
• You participate in and support site inspections and audits.

Requirements

• Master’s degree or equivalent in Pharmaceutical, Biotech, or Life Sciences.
• 3–5 years’ experience in the Biotech industry, preferably with CMC Regulatory Affairs.
• Knowledge and experience in regulatory registration and maintenance, GMP, manufacturing and/or quality operations, and interactions with Health Authorities. 
• Ability to work effectively in a matrix organization and cross-functional teams, collaborating with departments such as Global Regulatory Affairs, Global Quality, Supply Chain, and iCMC.
• Strong computer skills, including Word, Excel, PowerPoint, and experience with Regulatory Information Management systems.
• Strong organizational, analytical, negotiation, and problem-solving skills, with the ability to prioritize and deliver against challenging deadlines.
• Excellent interpersonal and communication skills, both written and verbal, and capable of working independently.
• Highly proficient in English, with strong technical and scientific writing skills. 

At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.

Together we make sure you get the most out of your career.