Overview
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.
Qualifications
* 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.
Additional Information
* The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
* We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
* This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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