Jobs in Canada

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Added 7 hours ago
EI
Emergency Planning & Security Specialist - 18 month term
Edmonton International Airport (YEG)
Edmonton, AB
- Contract
…manufacturing, sustainability, innovative technology development, and commercialization. The Airport City Sustainability Campus and the Alberta Aerospace and Technology Centre provide…
Added 10 hours ago
J&
Territory Manager (Ontario East and New Brunswick) - Johnson & Johnson MedTech, Circulatory Restoration (Shockwave IVL)
Johnson & Johnson Innovative Medicine
Markham, ON
- Full-time
Must have a valid driver’s license
Added 11 hours ago
M
Staff Software Architect - Flight Software
MDA
Brampton, ON
- Full-time
…knowledge in multi-disciplinary Engineering to help the department manager to improve/implement department-wide processes and practices related to all aspects of Software Engineering,…
Added 13 hours ago
Emergency Planning & Security Specialist - 18 month term
Edmonton Regional Airport Authority
Nisku, AB
…manufacturing, sustainability, innovative technology development, and commercialization. The Airport City Sustainability Campus and the Alberta Aerospace and Technology Centre provide…
Added 13 hours ago
V
Program Manager II
Verathon
Burnaby, BC
- Full-time
The Program Manager is responsible for leading and managing new product development (NPD) programs. This includes planning and managing program budget and spend, schedule, and requesting…
Added 14 hours ago
V
Program Manager II
Verathon
Burnaby, BC
- Full-time
The Program Manager is responsible for leading and managing new product development (NPD) programs. This includes planning and managing program budget and spend, schedule, and requesting…
Added 15 hours 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 15 hours 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 17 hours ago
C
Industry Development Manager
COVE
Halifax, NS
- Full-time
Reporting to the Director of Partnerships & Industry Development, the Manager, Industry Development leads the delivery and expansion of COVE’s Innovation Challenges Program, and related…
Added 1 day ago
GF
Electrical Engineer (Controls and Infrastructure)
General Fusion Inc.
Richmond, BC
- Full-time
…engineering-driven approach to fusion energy. General Fusion's commercialization program is anchored by LM26, the world's first commercially relevant-scale MTF demonstration machine. The…
Added 1 day ago
GF
Business Development Coordinator
General Fusion Inc.
Richmond, BC
- Full-time
…Magnetized Target Fusion, designed from the ground up with a commercialization in mind. At our lab in Richmond, BC, we're operating Lawson Machine 26 (LM26), our fusion demonstration…
Added 3 days ago
Sr. Manager, New Concepts & Add-ons
HelloFresh
Toronto, ON
The Senior Manager of New Concepts & Add-ons (Canada) leads HelloFresh Canada's new concepts and add-on portfolio, from strategic partner development through to commercial launch. This role…
Added 3 days ago
Research Security Specialist
University of Guelph
Guelph, ON
Reporting to the Manager, Research Risk, you will promote due diligence and research security awareness though the development, management and administration of policies, programs and…
Added 4 days ago
KD
Key Account Manager - Metro
Keurig Dr Pepper Canada
Mississauga, ON
- $86,200 to $115,000 CAD / year
- Full-time
The Key Account Manager is responsible for the effective development and implementation of the customer business plans for Metro Ontario/Food Basics. He/She will also be tasked with…
Added 4 days ago
B
HR Business Partner - Talent & Employee Relations
Bimeda
Cambridge, ON
- Full-time
Added 4 days ago
KD
Key Account Manager - Metro
Keurig Dr Pepper
Mississauga, ON
- $86,200 to $115,000 CAD / year
- Full-time
The Key Account Manager is responsible for the effective development and implementation of the customer business plans for Metro Ontario/Food Basics. He/She will also be tasked with…
Added 4 days ago
A
Product Development Lead
ARC'TERYX
North Vancouver, BC
- Full-time
Supporting the Manager, Product Development in building and coaching a team of technical Product Developers, and owning the day-to-day leadership and development of the team
Added 5 days ago
M
Staff Software Architect - Ground Control Software
MDA
Brampton, ON
- Full-time
…implementation, maintenance, and testing. Working with the department manager, you will strengthen engineering processes and practices, support commercialization, and mentor junior team…
Added 5 days ago
Q
FY27 Intern - Machine Learning Engineering Internship - Canada (4 months)
Qualcomm
Markham, ON
- Full-time
Support the implementation, optimization, and commercialization of AI algorithms and applications on Snapdragon devices.
Added 5 days ago
OT
Business Development Manager
Olympia Tile+Stone Inc.
Toronto, ON
- Full-time
We are seeking an experienced, results-driven Business Development Manager to drive Flextile's sales growth, market expansion, and strategic business development initiatives across Canada…
Added 5 days ago
P
Outbound Product Manager – 12 month contract
PointClickCare
Mississauga, ON
- Contract
Job Title: Outbound Product Manager – 12 month contract
Added 5 days ago
OT
Business Development Manager
Olympia Tile+Stone Inc.
Toronto, ON
- $60,000 CAD / year
- Full-time
We are seeking an experienced, results-driven Business Development Manager to drive Flextile's sales growth, market expansion, and strategic business development initiatives across Canada…
Added 5 days ago
T
Product Operations Manager
TEKsystems
Ottawa, ON
- $60 to $70 CAD / hour
- Contract
Build and run the reporting rhythm for the portfolio the single view of program health, launch status, and product performance that executive leadership and our board use to make decisions.
Added 6 days ago
CL
Quality Assurance - Quality Compliance Coordinator
Cosmetica Laboratories Inc
Toronto, ON · Scarborough, ON
- Full-time
Cosmetica is recognized for innovation, excellence, and commercialization with award-winning products. From concept to creation, we offer an unparalleled array of services that will…
Added 6 days ago
Industrial Technology Advisor - Various domains
National Research Council Canada
Montréal, QC
Organizational Unit: Industrial Research Assistance Program

AbCellera

Senior CMC Regulatory Affairs Manager

Montreal, QC, Canada

Apply on job-boards.greenhouse.io About employer

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 on job-boards.greenhouse.io 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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Work requirements

Jobs in Canada