Senior Manager, Biologics Regulatory Submissions

Regulatory Jobs; Worcester (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

AbbVie seeks a Senior Manager to lead analytical regulatory submissions for biologics, serving as lead author for Module 3 CTD sections S.2, S.4, S.5, and S.7. You will collaborate with Quality Control, QA, Regulatory, Analytical R&D, and CMC to deliver high-quality documentation for global submissions.

You will apply expertise in analytical methods, method validation, standard qualification, and stability studies, ensuring accuracy, regulatory compliance, and timely delivery in a fast-paced

Qualifications

• Bachelor’s degree in Chemistry, Physical/Life Sciences, Engineering, or related field.
• 8+ years in CMC, Manufacturing, QA/QC, R&D in pharma or biologics.
• 4+ years of supervisory/technical leadership experience.
• Extensive authoring experience with Module 3 CTDs (S.2.3, S.4.2, S.4.3, S.5, S.7).
• Strong knowledge of global regulatory requirements and ICH guidelines.
• Excellent written and verbal communication with high attention to detail.
• Experience with statistical quality systems and electronic document management.
• Familiar with cGMP and other regulatory requirements.

Responsibilities

• Author and review new applications and amendments for CTD Module 3 sections S.2, S.4, S.5, and S.7 for regulatory submissions.
• Support responses to regulatory questions and information requests.
• Lead cross-functional project meetings to support timelines and deliverables.
• Interact and collaborate with teams to gather and interpret technical data.
• Remain up to date with regulatory requirements relevant to Module 3 content.
• Demonstrate ability to identify risks and propose solutions for documentation challenges.

Skills

Regulatory submissions

Analytical methods

CMC

Team leadership

Stability studies

Education

Bachelor’s degree in Chemistry, Physical or Life Sciences, Engineering

Job description

AbbVie seeks a Senior Manager to lead analytical regulatory submissions for biologics, serving as lead author for Module 3 CTD sections S.2, S.4, S.5, and S.7. You will collaborate with Quality Control, QA, Regulatory, Analytical R&D, and CMC to deliver high-quality documentation for global submissions.

You will apply expertise in analytical methods, method validation, standard qualification, and stability studies, ensuring accuracy, regulatory compliance, and timely delivery in a fast-paced