New · posted Nov 11
AbbVie · Pharmaceuticals
Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
- North Chicago, IL +1 more
- Hybrid
- Full-time
- Manager
The role
The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice.
What you need
What you'll do
- Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
- Responds to global regulatory information requests.
- Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
- Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
- Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
- Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization
- Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA CMC.
Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company. - This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
- Required Education: Bachelor’s degree in pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject. Preferred Education: Relevant advanced degree preferred. Certification a plus.
- Required Experience: 8 years’ pharmaceutical experience. Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
- Note: Higher education may compensate for years of experience
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 long-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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$125,000 – $237,000 a year
Employer providedPaid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Long-term incentive programs
Where you'll work
North Chicago, IL +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Waltham, MA
More jobs in North Chicago, IL +1 more
From the posting
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
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.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Manager roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $125,000 | — | $237,000 |
| All US (middle half) | $142,000 | $152,500 | $166,250 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 89 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions6
- Documentation and SOPs4
- Collaboration and leadership4
- GMP and compliance2
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory CMC work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q11(official source, opens in a new tab)Development and manufacture of drug substances
- ICHICH Q12(official source, opens in a new tab)Lifecycle management of post-approval chemistry, manufacturing and controls changes
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- ICHICH M7(official source, opens in a new tab)Assessment and control of mutagenic impurities
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
Company hiring pulse
AbbVie on Regulatory Jobs
- 74
- Open roles
- 74
- Distinct roles
- 17
- Locations
By discipline
- Clinical60 52%
- Quality29 25%
- Regulatory26 23%
By level
- Director52 45%
- Manager28 24%
- Senior & Principal20 17%
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Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) at AbbVie
Open until filled. $125K–$237K a year, employer provided.