Quality Senior Manager (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's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at

www.abbvie.com

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About the Role: We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval. The ideal candidate will have extensive analytical experience, including authoring of analytical and stability regulatory submission sections, a proven track record of excelling in a fast-paced environment, and outstanding attention to detail.

Scope of 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 (e.g., BLAs, MAAs, INDs, IMPDs, etc). Support responses to regulatory questions and information requests.

Provide subject matter expertise in analytical methods, method validation, reference standard qualification, and stability studies.

Ensure consistency, accuracy, and compliance of submission documents with current regulatory guidance and company standards.

Remain up to date with regulatory requirements relevant to Module 3 content.

Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise to deliver results within project timelines.

Proactively identify risks and propose solutions for documentation challenges.

Lead cross-functional project meetings to support timelines and project deliverables.

Interact and collaborate with teams to gather and interpret technical data.

Minimum Bachelor’s Degree required preferably in Chemistry, Physical or Life Sciences, Engineering, or related subject; relevant advanced degree preferred.

8+ years of combined experience in CMC, Manufacturing, QA, QC, R&D in pharmaceutical, or biologics industry.

4+ years of supervisory/technical leadership experience.

Extensive authoring experience with Module 3 CTDs (specifically S.2.3, S.4.2, S.4.3, S.5, S.7) for regulatory submissions.

Proven expertise in analytical/quality control laboratory or CMC regulatory environment.

Strong understanding of global regulatory requirements and ICH guidelines.

Demonstrated ability to work effectively on teams and build collaborative relationships across functions.

Excellent written and verbal communication skills; attention to detail is essential.

Self-motivated, organized, and capable of managing multiple priorities and deadlines independently.

Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.

Must be familiar with use of statistical quality systems and electronic document management system.

Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.