Regulatory Affairs Lead (Manufacturing, Remote)

Job summary

An experienced Regulatory Affairs leader is needed to provide regulatory oversight at a manufacturing site, ensuring compliance with regulatory standards and efficient operations. This role involves close collaboration with global and onsite regulatory teams to support manufacturing initiatives and maintain inspection readiness.

Qualifications

• Bachelor’s degree in a scientific or engineering field; advanced degree is a plus.
• Over 8 years of experience in regulatory affairs or a related field within regulated manufacturing sectors such as IVDs or medical devices.
• In-depth knowledge of GMP requirements and manufacturing processes.
• Experience in managing regulatory inspections and audits, with direct engagement with health authorities.
• Ability to assess regulatory risks and manage complex workloads in a matrix organization.
• Strong analytical and communication skills, capable of translating regulatory requirements into actionable guidance.

Responsibilities

• Provide regulatory leadership focused on manufacturing processes and GMP compliance.
• Lead regulatory efforts for audits and inspections, ensuring documentation is always inspection-ready.
• Advise site management on regulatory workload associated with initiatives and programs.
• Conduct independent research on regulatory requirements to inform site-specific strategies.
• Serve as the primary regulatory contact for site leadership and cross-functional teams.
• Communicate regulatory risks and recommendations effectively to leadership, escalating issues with analysis and proposed solutions.

Skills

• Trusted advisor with a solutions-oriented approach.
• Ability to remain calm and confident under pressure during inspections.
• Strong collaborative skills to build relationships at the site level.
• Capability to balance regulatory compliance with manufacturing efficiency.
• Comfortable working independently while aligning with global regulatory strategies.

Education

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.

Tools

• Familiarity with regulatory documentation and compliance management tools.