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Added 1 day ago
H
IT Project Manager
HrBrain
Featured · Posted directly by employer
Waterloo, ON
- $70 CAD / hour
- Contract
Bachelor’s degree in Computer Science, Information Technology, Engineering, Business, or a related field, or equivalent practical experience.
Added 13 mins ago
LM
PROJECT CONTROLS / SCHEDULER - LONDON SITE
Laframboise Mechanical Electrical Ltd
London, ON
- Contract
…multiple project schedules for LGL. Works directly with Project Manager and team to fully understand project scope to create project schedule based on information, duration, and task…
Added 13 mins ago
LG
PROJECT CONTROLS / SCHEDULER - LONDON SITE
Laframboise Groupe
London, ON
- Contract
…multiple project schedules for LGL. Works directly with Project Manager and team to fully understand project scope to create project schedule based on information, duration, and task…
Added 13 mins ago
CO
Inventory Services and Control Manager
City of Iqaluit
Iqaluit, NU
- Full-time
The City of Iqaluit is seeking an experienced Inventory Services & Control Manager to lead procurement, contracting, inventory control, warehouse operations, shipping and receiving, and…
Added 13 mins ago
NS
Project Leader - Cape Breton Redevelopment Project
Nova Scotia Health Authority
Sydney Indian Reserve No. 28A, NS · Sydney, NS
- $45.75 to $56.04 CAD / hour
- Temporary
Registered Engineer in a relevant Engineering discipline having 3-5 years project management experience; or
Added 13 mins ago
IG
Senior Manager of OSP Construction
Insight Global
Concord, ON
- Full-time
The Sr. Manager of Construction leads a multi-disciplined workforce to complete the construction of complex network deployment projects as well as a service workforce created to support…
Added 13 mins ago
O
Manager, Facilities
OpenText
Waterloo, ON
- Full-time
The Manager, Facilities Management is the senior site leader responsible for the safe, reliable, compliant, and cost-effective operation of OpenText’s Waterloo real estate portfolio,…
Added 13 mins ago
AC
PROJECTS COORDINATOR
Albarrie Canada Limited
Barrie, ON
- Full-time
Under the direction of the Project Manager, US & Facilities, the Projects Coordinator is responsible for planning, coordinating, and executing minor capital projects, facility improvements,…
Added 13 mins ago
KG
Transmission Line Engineer
Kosmos Group
Burnaby, BC
- Full-time
Kosmos Group is an engineering consulting firm specializing in electrical power generation, transmission, substations, and distribution. We support public and private utilities,…
Added 14 mins ago
YI
Quality Assurance Supervisor
Young Innovations
Brantford, ON
- Other
…hiring a Quality Assurance Supervisor. Reporting to the Quality Manager, this is a hands-on leadership role with accountability for the day-to-day health of the QMS, including…
Added 14 mins ago
T
Kubernetes Engineer II
TD
Toronto, ON
- Full-time
You will work in collaboration with cloud engineering, network, security, and risk management to deliver bank secured solutions that meet security policies and standards within TD. You will…
Added 14 mins ago
T
Business Information Management Specialist-1
TD
Toronto, ON
- Full-time
7+ years of experience in data management, data engineering, data analysis, data governance, or a related discipline, with demonstrated hands-on data experience.
Added 14 mins ago
T
Business Information Management Specialist-2
TD
Toronto, ON
- Full-time
7+ years of experience in data management, data engineering, data analysis, data governance, or a related discipline, with demonstrated hands-on data experience.
Added 14 mins ago
T
Data Scientist II
TD
Toronto, ON
- Full-time
Undergraduate or advanced technical degree (e.g., math, statistics, engineering, finance, or computer science); graduate's degree preferred with progressive work experience
Added 14 mins ago
X
Concrete Scanning/Coring Technician Trainee
Xradar
Halifax, NS
- Full-time
Assisting with concrete engineering surveys and developing technical skills.
Added 14 mins ago
Vice President of Operations
Northern911
Sudbury, ON
…excellence. You will also partner with RapidSOS product and engineering teams to put new technology to work in a live 24/7…
Added 14 mins ago
Street Team Member - Corus Radio Toronto (Q107, 102.1 The Edge, 640 Toronto)
Corus Entertainment
Toronto, ON
Technical Engineering of on location sales and programming remotes.
Added 14 mins ago
B
Senior Project Manager
BGIS
Ottawa, ON
- Full-time
The Senior Project Manager plans and oversees the end-to-end delivery of assigned projects and ensures delivery within scope, budget and requirements. At this level, projects are typically…
Added 14 mins ago
Senior CMC Regulatory Affairs Manager
AbCellera
Montreal, QC
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…
Added 14 mins ago
B
Technical Service Analyst
Boeing
Ottawa, ON · CAN - Ottawa, Canada
- Full-time
…Program (MHLH) reporting to the MHLH Technical Integration Manager working out of the Ottawa, Ontario…
Added 14 mins ago
BU
Partnership Development Manager
Brock University
St. Catharines, ON · Main Campus (Employees)
- Full-time
Reporting to the Associate Director, Partnership Development, the Partnership Development Manager is responsible for managing Brock University's research partnership and business…
Added 14 mins ago
B
Technical Service Analyst
Boeing
Ottawa, ON · CAN - Ottawa, Canada
- Full-time
…Program (MHLH) reporting to the MHLH Technical Integration Manager working out of the Ottawa, Ontario…
Added 14 mins ago
Conception Manager
Pomerleau
Halifax, NS
During the proposal and execution phases of projects delivered under alternative delivery methods, the design manager manages design packages within a large-scale project or oversees the…
Added 28 mins ago
CO
Inventory Services and Control Manager
City of Iqaluit
Iqaluit, NU
- Full-time
The City of Iqaluit is seeking an experienced Inventory Services & Control Manager to lead procurement, contracting, inventory control, warehouse operations, shipping and receiving, and…
Added 28 mins ago
Manager, Business Enablement
Trans Mountain
Calgary, AB
Trans Mountain is seeking a collaborative, motivated, and values driven individual to join our dynamic team as a Manager, Business Enablement. In this position, you will Lead Trans…
Added 44 mins ago
CS
Capital Project Manager
CQ Search Group Ltd.
Oshawa, ON · Greater Oshawa Metropolitan Area
- $130,000 to $140,000 CAD / year
- Full-time
Our client, a leading CPG manufacturing organization, is seeking an experienced Engineering/Capital project Manager to lead and execute large-scale capital projects across its manufacturing…

AbCellera

Senior CMC Regulatory Affairs Manager

Montreal, QC, Canada

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Applications open in a new tab.

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.

Apply About employer

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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