ATD Senior Regulatory Specialist

Agilent Technologies•Boulder, CO

2d•$97,920 - $153,000

About The Position

The Senior Regulatory Specialist serves as the primary regulatory partner for Agilent’s external pharmaceutical and biotechnology clients. The role provides CMC information and documentation for regulatory submissions, responses to health authority questions during submission review, and post-approval obligations. It also collaborates with internal R&D, Quality, Manufacturing, and Commercial teams on change management, regulatory intelligence, and external audit support.

Requirements

Bachelor’s degree or equivalent in chemistry or a related life science field.
At least 3 years of regulatory experience in pharmaceuticals and/or biologics.
Experience with global pharmaceutical good manufacturing practices (GMP), including 21 CFR Parts 210 and 211.
Knowledge of drug submission and approval pathways, specifically CMC requirements for drugs and biologics.
Ability to manage work groups representing multiple functional groups, process areas, and regions.
Ability to engage and communicate effectively with clients and government inspectors.
Familiarity with confidentiality agreements and policies protecting clients’ and other external parties’ intellectual property and proprietary information.
Exceptional problem-solving, issue-resolution, and negotiation skills.
Proficiency with the MS Office Suite, including Outlook, Word, Excel, PowerPoint, and Teams.

Nice To Haves

Knowledge of and/or experience with gene therapies and gene-editing programs.
Regulatory Affairs Certification (RAC), Pharmaceutical Regulations.

Responsibilities

Understand applicable regulations, guidance documents, and industry standards.
Support regulatory intelligence activities, including preparing gap assessments and coordinating cross-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 by 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 according to applicable procedures.
Support internal teams during client and regulatory audits, including preparing documents, coaching subject-matter experts, and assisting with inspection-readiness activities.