ATD Senior Regulatory Specialist

Job Description

The Regulatory Affairs Specialist is the primary regulatory partner for Agilent’s 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.

Overall Responsibilities

• 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

Qualifications

Education

• Bachelor’s 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

Travel Required:

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