ATD Senior Regulatory Specialist

The Regulatory Affairs Specialist is the primary regulatory partner for Agilents external pharmaceutical and biotechnology clients and provides CMC information and documentation to support their regulatory submissions responses to health authority questions during submission review and helping meet post-approval obligations. The role also works with internal teams including R&D Quality Manufacturing and Commercial teams on tasks such as change management regulatory intelligence and supporting external audits.

• Understand applicable regulations guidance documents and industry standards
• Support regulatory intelligence activities including preparing gap assessments and coordinating multi-functional efforts to remediate identified gaps
• Respond to client regulatory questions and document requests
• Maintain internal regulatory documents for compliance including Site Master Files
• Provide regulatory guidance and training to cross-functional teams
• Maintain site registrations with health authorities including product and national drug codes (NDCs)
• Support Quality Assurance through writing reviewing and approving documents as assigned.
• Review and assess change management records for regulatory impact
• Ensure audit records and supporting documentation are complete traceable and retained in accordance with applicable procedures
• Support internal teams during client and regulatory audits including document preparation and coaching subject-matter experts and assisting with inspection-readiness activities

Education

• Bachelors degree or equivalent in chemistry or related life science field is required

Experience

• Minimum 3 Years of regulatory experience pharmaceuticals and/or biologics is required
• Experience with global pharmaceutical good manufacturing practices (GMP) including 21 CFR Parts 210 and 211 as well as knowledge of drug submission and approval pathways specifically chemistry manufacturing and controls (CMC) requirements for drugs and biologics is required
• Knowledge and/or experience with gene therapies and gene-editing programs preferred

Essential Skills

• Managing work groups representing multiple functional groups process areas and regions
• Effectively engaging and communicating with clients and government inspectors
• Familiarity with confidentiality agreements and understanding policies to protect intellectual property and proprietary information of clients and other external parties.
• Exceptional problem solving issue resolution and negotiation skills
• MS Office Suite (Outlook Word Excel PowerPoint Teams)

Certification(s)

• Regulatory Affairs Certification (RAC) Pharmaceutical Regulations Preferred
  
  

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least October 22 2026 or until the job is no longer posted.

The full-time equivalent pay range for this position is $97920.00 - $153000.00/yr plus eligibility for bonus stock and benefits. 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: Technologies Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals regardless of personal characteristics are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex pregnancy race religion or religious creed color gender gender identity gender expression national origin ancestry physical or mental disability medical condition genetic information marital status registered domestic partner status age sexual orientation military or veteran status protected veteran status or any other basis protected by federal state local law ordinance or regulation and will not be discriminated against on these bases. Agilent Technologies Inc. is committed to creating and maintaining an inclusive in the workplace where everyone is welcome and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility please email or contact 1-. For more information about equal employment opportunity protections please visit Required: Occasional

Day

No End Date

Quality/Regulatory