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.
Key Responsibilities
-
Manufacturing‑Focused Regulatory Leadership
Provide hands‑on regulatory leadership aligned with site manufacturing processes and GMP requirements. Proactively identify regulatory impacts of site changes (e.g., process, equipment, materials, suppliers) and ensure they are assessed early and managed effectively through appropriate regulatory pathways.
-
Audit & Inspection Readiness
Serve as the regulatory lead for health authority and customer audits at the Glostrup site, with a strong “front‑room” presence. Ensure regulatory documentation, data, and evidence are inspection‑ready at all times, and respond confidently, consistently, and clearly to regulatory‑related audit questions.
-
Regulatory Resource & Project Prioritization
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.
Qualifications
-
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.
Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
**Travel Required: **
Occasional
**Shift: **
Day
**Duration: **
No End Date
**Job Function: **
Quality/Regulatory