Assess and advise managers on the workload associated with site‑driven initiatives and programs.
Regulatory Research & Interpretation
Independently research, interpret, and apply external regulatory requirements, guidance, and precedents to address site‑specific regulatory questions and inform regulatory strategy and recommendations.
Cross‑Functional Partnership
Act as the primary regulatory contact for site leadership and key cross‑functional partners including Manufacturing, MSAT, Quality, and Program Management to enable compliant execution of site objectives.
Regulatory Communication & Escalation
Clearly communicate regulatory risks, options, and recommendations to site and global regulatory leadership, escalating issues as appropriate with well‑reasoned analysis and proposed mitigation strategies.
Requirements
Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
8+ years of regulatory affairs experience (or related discipline) within regulated manufacturing environments (IVDs, medical devices, or related life sciences).
Strong understanding of GMP requirements, manufacturing processes, and post‑approval change management.
Demonstrated experience supporting regulatory inspections and audits, including direct interaction with health authorities and customers.
Proven ability to assess regulatory risk, prioritize complex workloads, and support site‑level execution in a matrixed organization.
Strong analytical, communication, and influencing skills with the ability to translate regulatory requirements into practical, actionable guidance.
Personal Characteristics
Trusted regulatory advisor with a practical, solutions‑oriented mindset
Confident and calm under inspection or audit pressure
Highly collaborative, with the ability to build strong relationships at the site level
Able to balance regulatory rigor with manufacturing efficiency
Comfortable operating independently while aligning with global regulatory strategy
Additional Details
This job has a full time weekly schedule.
Travel Required:
Occasional
Shift:
Day
Duration:
No End Date
Job Function:
Quality/Regulatory
Benefits
Health insurance
Additional Information
Job Description
We are seeking an experienced Regulatory Affairs leader to serve as the Regulatory Site Lead for the Glostrup manufacturing site. This Expert Level role provides on‑site regulatory leadership with a strong manufacturing focus, ensuring regulatory considerations are embedded early into site initiatives and day‑to‑day operations. This leader interacts closely with global and onsite regulatory colleagues.
The Regulatory Site Lead is a key regulatory partner to site leadership and cross‑functional teams, supporting compliant and efficient manufacturing operations, inspection readiness, and supply continuity. This role acts as the primary regulatory interface for site changes, audits, and regulatory inquiries, translating regulatory requirements into clear, practical guidance at the site level.
Agilent · Denmark