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Added 13 mins ago
R|
Project Manager
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Contract
Data quality and research operations: Identify and resolve data-quality issues, develop standardized procedures, and quality-control processes.
Added 13 mins ago
W
Project Manager
Weatherhaven
Brockville, ON
- Full-time
Weatherhaven is seeking an experienced, technically capable and delivery-focused Project Manager to oversee a portfolio of engineering and manufacturing projects for military, government…
Added 13 mins ago
CF
Technical Product Manager
Centre for Effective Practice
Toronto, ON
- Full-time
…frontline providers have the information they need to deliver high-quality care and improve patients' health outcomes. In Ontario alone, our work reaches over 18,000 healthcare providers…
Added 13 mins ago
B
Stockpile and Ship loading Superintendent
Baffinland
Pond Inlet, NU
- Full-time
Reporting to the Manager of Crushing and Transportation, the Stockpiling and Shiploading Superintendent is accountable for the safe and efficient operation of stockpiling iron ore at Milne…
Added 13 mins ago
LV
ASSISTANT MANAGER-EN
La Vie En Rose
NL · Creston, NL
- Full-time
With the support of your manager, you will be responsible for making sure the store runs smoothly and that your team provides the best possible customer service. When you’re working as…
Added 13 mins ago
SC
Senior Accountant
Steinbach Credit Union
Steinbach, MB
- Full-time
As a Senior Accountant, you’ll be a trusted member of our Finance team, reporting to the Manager, Accounting. You’ll own full-cycle accounting operations and play a hands-on role in…
Added 13 mins ago
OH
QA/QC Regulatory Officer
Omnia Holdings
Sudbury, ON
- Full-time
Job Family QUALITY AND LABORATORY Job Grade C4
Added 13 mins ago
K
Foreperson
Kalamoir
Coaldale, AB
- Full-time
…daily site activities, runs the site safety program, verifies quality and provides hands off support as needed. The Foreman reports to the Site Superintendent or Construction…
Added 13 mins ago
K
Superintendent
Kalamoir
Claresholm, AB
- Full-time
…daily site activities, runs the site safety program, verifies quality and provides hands off support as needed. This role reports to the Construction…
Added 13 mins ago
A
Gestionnaire principal(e) de projets
ABB
Montreal, QC
- Full-time
The Senior Project Manager leads the execution of complex mining electrification projects, ensuring delivery in line with scope, schedule, budget, and quality requirements. Working closely…
Added 13 mins ago
DI
Research Supply Manager
Dig Insights
Toronto, ON · Greater Toronto Area, Canada
- Full-time
The Research Supply Manager runs the sourcing of external sample and fieldwork for Dig’s projects, and is accountable for the cost and margin outcome of those decisions on each project. The…
Added 13 mins ago
KC
Senior Electrical Designer & Team Lead
Kepler Communications Inc.
Toronto, ON · Greater Toronto Area, Canada
- Full-time
…to the required standards of performance, reliability, and…
Added 13 mins ago
MC
Beverage Quality Analyst - Temp
Molson Coors Beverage Company
Chilliwack, BC
- Temporary
In the role of Temporary Beverage Quality Control Analyst at our Chilliwack Brewery you will perform monitoring, training and expert problem-solving related to the maintenance of quality…
Added 13 mins ago
MN
Electrical Project Manager
Modern Niagara Building Services
Vaughan, ON
- $100,000 to $120,000 CAD / year
- Full-time
The Electrical Project Manager leads electrical construction projects from planning and procurement through installation, commissioning, and closeout. Based in our Vaughan office, this role…
Added 13 mins ago
A
Service Manager
AutoCanada
Maple Ridge, BC
- $120,000 to $150,000 CAD / year
- Other
…customer relationships and ensuring repeat customers by delivering quality service, recommending additional products and services and by addressing any customer concerns or complaints…
Added 13 mins ago
R
Project Manager – Infrastructure
Raise
Burnaby, BC
- Full-time
Work Package Management: Oversee and hold overall accountability for the planning, execution, and quality of work packages managed by Work Package Managers.
Added 13 mins ago
Research Assistant 2 - Slaight Centre Research
CAMH
Toronto, ON
- Experience with data entry, data management, and quality control
Added 13 mins ago
ASSISTANT MANAGER
Boutique La Vie En Rose
NL · CRESTON, NL
With the support of your manager, you will be responsible for making sure the store runs smoothly and that your team provides the best possible customer service. When you’re working as…
Added 13 mins ago
Electronics Manufacturing Engineer
Toradex
ON
Reporting to the Operations and Manufacturing Manager, the successful candidate will work closely with Production, Engineering, Quality, Operations, and leadership to turn improvement…
Added 28 mins ago
IM
Manager, Financial Reporting
Investment Management Corporation of Ontario (IMCO)
Toronto, ON
- Full-time
The Manager, Financial Reporting leads the preparation of financial statements and related disclosures for IMCO’s investment pool funds and assigned investment legal entities in accordance…
Added 28 mins ago
SF
Quality Assurance Technician - Morning Shift
Sunrise Farms
Cloverdale, BC
- Full-time
Quality Control Technician is responsible for evaluating and assessing that HACCP and Quality Assurance Programs are properly maintained in compliance with regulatory guidelines though…
Added 28 mins ago
BE
Project & Construction Manager
Blackstone Energy
Niagara Falls, ON · Niagara Region, Ontario
- Full-time
Practical understanding of construction sequencing, drawings and specifications, site safety, quality control, change management, procurement and commissioning.
Added 42 mins ago
CG
Supervisor - Full-Time
Compass Group Canada
Alliston, ON
- Full-time
Learn from and assist the Shift Manager to resolve labour relation issues, track and produce reports on weekly inventories, sales revenue, labour and food cost.
Added 43 mins ago
SD
Merchandiser, Hourly Part Time Flexible Shifts
Shoppers Drug Mart
Waterloo, ON
- Part-time
Supports Front Store Manager/Assistant Front Store Manager in maintaining the quality and standards
Added 43 mins ago
B&
Project Coordinator - Electrical ICI
Black & McDonald Limited
Toronto, ON · GTA, ON
- Full-time
Project Coordinators assist with planning, organization, direct, control and evaluate assigned project(s) from start to finish and in accordance with schedule, specifications and budget.…

AbCellera

Senior CMC Regulatory Affairs Manager

Montreal, QC, Canada

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Job details

Posting language: English
Posted: Nov 9, 2026

Original job description

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown, and go one step beyond.

We are seeking a Senior CMC Regulatory Affairs (RA) Manager who will work closely with our Manufacturing and Quality teams to implement and document global CMC strategies for multiple biologics programs, from pre-clinical development through Phase 3 studies and commercialization. You will be a key member of cross-functional project teams, helping to shape the CMC regulatory strategy and documentation for innovative new biologics and ensuring submissions are aligned with global health authority requirements and delivered on time with quality.

How you might spend your days

Leading the planning, authoring, review, and execution of global CMC regulatory submissions, including health authority briefing documents, Module 3 content for INDs, IMPD/QOS, CTAs, and other regulatory filings
Leading or contributing to the development of responses to health authority queries
Providing strategic CMC regulatory guidance and critical review of technical documentation, including validation protocols and reports, to ensure CMC strategies and supporting data are scientifically sound, compliant with global regulatory expectations, effectively presented within high-quality regulatory submissions
Managing critical CMC regulatory timelines and deliverables, partnering closely with Manufacturing, Quality, and Analytical Development teams to support development and registration objectives
Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
Identifying regulatory CMC program risks, assessing potential impact to development programs, and establishing mitigation strategies
Assessing CMC change controls for regulatory impact and ensuring ongoing compliance with global regulatory filings
Partnering with CMC, Discovery, Quality, and Clinical Development teams to innovate strategies to accelerate submission timelines and work as a key member of project teams

We’d love to hear from you if

You have a deep understanding of CMC regulatory requirements, eCTD structure, and experience in Module 3 preparation and authoring (INDs/IMPDs and BLAs/NDAs/NDSs) for biologics and combination products
You have experience developing and executing CMC regulatory strategies and submissions for biologics and combination products, including pre-filled syringes, auto-injectors, and other drug-device delivery systems, with a strong understanding of associated regulatory documentation requirements
You have a thorough understanding of Health Canada, FDA, and EMA regulations
You are a skilled regulatory professional and technical writer with effective oral communication skills
You are a detailed-oriented individual, highly organized, and thrive in fast paced environments while managing multiple priorities.
You hold an advanced degree or Bachelor’s degree in biological, pharmaceutical, chemical, engineering sciences, or a related sciences, plus about 8 years of relevant work experience

What we offer

In addition to base salary, we offer equity, annual bonus dependent on individual and company performance, and a 6% (non-match) RRSP contribution.

You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.

About AbCellera

Creating medicines is the most important work we can do.

We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline.

Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.

We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.

We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.

To apply

Please submit your application through our website and refer to Job ID 23397 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.

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More about this job

Responsibilities

Lead the planning, authoring, and execution of global CMC regulatory submissions for biologics programs from pre-clinical to commercialization. Partner with cross-functional teams to provide strategic guidance, manage regulatory timelines, and ensure compliance with global health authority requirements.

Requirements

Requires an advanced or bachelor's degree in a relevant scientific field and approximately 8 years of experience in CMC regulatory affairs. Candidates must possess deep knowledge of biologics, eCTD structures, and regulatory requirements for FDA, EMA, and Health Canada.

Skills

CMC regulatory strategy
Biologics
Regulatory submissions
Module 3 preparation
Technical writing
Health authority interaction
IND
IMPD
BLA
NDA
Drug-device delivery systems
Change control
Regulatory compliance
Project management
Cross-functional collaboration
Risk mitigation

Benefits

Equity
Annual bonus
RRSP contribution
Active lifestyle allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits

Visa sponsorship

Not detected in the job text

Keywords

CMC
Regulatory Affairs
Biologics
IND
IMPD
BLA
NDA
eCTD
Module 3
Health Canada
FDA
EMA
Drug-device
Pre-filled syringes
Auto-injectors
Validation protocols
Change control
Regulatory intelligence
Biotechnology
Antibody-based medicines
Clinical development
Manufacturing
Quality assurance
Analytical development
Regulatory strategy

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