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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
KE
Content Specialist
K’awat’si Economic Development Corporation (KEDC)
Port Hardy, BC
- $65,000 to $70,000 CAD / year
- Full-time
…turn your copy into finished art, and report to the Marketing…
Added 13 mins ago
IC
Data Scientist, SAS-to-Python Migration
Infotek Consulting Inc.
Toronto, ON
- $80 to $95 CAD / hour
- Contract
Actual Job Title: Data Scientist, SAS-to-Python Migration (Expert)
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
Wealth Operations Analyst I
TD
Toronto, ON
- Full-time
Prioritize and complete own workload to meet SLA requirements for service and productivity and or support team manager in prioritizing and managing team workload, demonstrating a proactive…
Added 14 mins ago
Marketing Manager, Consumer Products & Brands
Blue Ant Media Inc.
Toronto, ON
The Marketing Manager, Consumer Products and Brands will lead consumer products marketing and brand building for a portfolio of entertainment and consumer properties. You’ll grow audiences,…
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
TO
Coordinator, Gift Processing
The Ottawa Food Bank
Ottawa, ON
- Full-time
Reporting to the Manager, Data & Donor Operations, the Coordinator, Gift Processing is responsible for the accurate and timely processing of donations, tax receipting, donor record…
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 28 mins ago
M
Account Executive
Mirego
Toronto, ON
- Full-time
At the heart of Mirego’s growth, your role as a Business Development Manager for the Toronto area is essential to identifying and qualifying new opportunities. As the first point of contact…
Added 28 mins ago
Client Services Officer
Scotiabank
Montreal, QC
Provides support to Relationship Managers and the District Director/ District Manager on new and existing deals by:
Added 28 mins ago
Client Services Officer, Roynat Capital
Scotiabank
Toronto, ON
Provides support to Relationship Managers and the District Director/ District Manager on new and existing deals by:
Added 43 mins ago
OV
Buying Manager
October's Very Own
Toronto, ON
- $90,000 to $120,000 CAD / year
- Full-time
The Buying Manager owns assortment strategy across all OVO categories, building ranges that are commercially balanced and true to the brand. This role drives seasonal inventory investment…
Added 43 mins ago
C
Manager, Strategy Consultant
Coactuate
Toronto, ON
- Full-time
…healthcare/life sciences, pharmaceutical/biotech, and/or market research/analytics where strategic thinking and client leadership have been foundational to their…
Added 43 mins ago
Digital Analyst
Hydro One Networks Inc
Toronto, ON
Requires experience with various software applications such as Google Analytics, Google Tag Manager, Hootsuite and Looker Studio (Data Studio) and Microsoft Clarity.
Added 43 mins ago
RM
Assistant Technical Audit Team
Regional Municipality of Peel
Brampton, ON
- Other
Reporting to the Program Manager, Policy Research and Business Strategies, you will assist with organizing and preparing waste composition data for the Waste planning team.
Added 43 mins ago
Administrative Coordinator
University of Toronto
Toronto, ON
…strength of Arts & Science derives from our combined teaching and research excellence in the humanities, sciences and social sciences across 29 departments, seven colleges and 46…
Added 1 hour ago
IC
Digital Marketing Specialist
i24 Call Management Solutions
Montreal, QC
- Part-time
…handling, web-form email management, remote worker monitoring, and data management. Recognized as one of the most technologically advanced call management services in North America, i24…
Added 1 hour ago
A
Laboratory Assistant
ALS
North Vancouver, BC · CAN - BC - North Vancouver
- Full-time
When you join us, you’ll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future.
Added 1 hour ago
Senior Digital Broadcast Journalist - Global National News
Corus Entertainment
Toronto, ON
Incorporating data, research, and expert perspectives to strengthen storytelling and provide context.
Added 1 hour ago
CF
Production Manager
Capsule Factory Nutraceuticals
Woodstock, ON
- Full-time
The Production Manager leads Capsule Factory’s manufacturing operation and is accountable for producing safe, high-quality natural health products on schedule and at target cost. The role…
Added 1 hour ago
Project Manager, Market Strategy & Understanding
Ipsos
Toronto, ON
As a Project Manager, you will be a key member of a team of dynamic and passionate professionals. The role will assist with functional and technical knowledge and help with the deployment…
Added 1 hour ago
UO
Finance Service Partner
University of Alberta
Edmonton, AB
- Full-time
As a Finance Partner, you will act as a strategic professional advisor to the dean, faculty general manager, or other senior leaders such as Associate Vice President within your portfolio.…
Added 1 hour ago
BC
Purchasing Administrator - Buildings West
Bird Construction
Edmonton, AB
- Full-time
Support Purchasing Manager on daily administrative tasks

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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