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Added 11 mins ago
BC
Marketing Specialist
BK CONSULTING GABON
Canada
- Full-time
Develop and manage content for websites, social media platforms, email campaigns, and promotional materials.
Added 11 mins ago
R
Station Technician-in-Charge
Radio-Canada
Windsor, ON
- Full-time
At CBC/Radio-Canada, we create content that informs, entertains and connects Canadians on multiple platforms. Our successes and accomplishments are driven by embodying and upholding values,…
Added 11 mins ago
C3
Systems Administrator
Company 3
Toronto, ON
- $33.65 to $43.27 CAD / hour
- Full-time
…editorial, VFX, and audio mixing environments. Working alongside Senior Systems Engineers, this role ensures studio infrastructure remains reliable, performant, and secure by implementing…
Added 11 mins ago
TR
Sr. Legal AI Prompter, Evaluator
Thomson Reuters
Toronto, ON
- Full-time
…legally sound outputs that legal professionals can trust. As senior members of the team, they take a leading role in the hands-on development of LLM-driven solutions, design and run…
Added 11 mins ago
ES
Data Analyst - EA Sports FC
EA SPORTS
Vancouver, BC
- Full-time
The FC Data & Analytics team is seeking a Data Analyst to join our team based in Vancouver. Reporting to a Senior Manager, you will collaborate closely with production, product management,…
Added 41 mins ago
PB
Director of SEO
Powered by search
Remote, Canada
- Full-time
- Remote
This Role Is Not About Publishing Content or Fixing Tags. It’s about owning revenue, retention, and the standard of excellence for SEO and AI Search at Powered by Search.
Added 56 mins ago
A
Principal Engineer - Open Source Data Platform (ODP)
Acceldata
Kitchener, ON
- Full-time
Mentor Staff Engineers and Senior Engineers; develop technical leadership capabilities across the organization.
Added 56 mins ago
C
Senior Director, Content
Cossette
Toronto, ON
- $120,000 to $170,000 CAD / year
- Full-time
We’re looking for a Senior Director, Content who knows how to take a creative idea and turn it into a piece of work people actually want to watch.
Added 1 hour ago
KE
Content Specialist
K’awat’si Economic Development Corporation (KEDC)
Port Hardy, BC
- $65,000 to $70,000 CAD / year
- Full-time
…of our mandate and of how we work every day. We are hiring a Content Specialist to write and manage content for our businesses across social media, brochures, print and digital ads, case…
Added 1 hour ago
KE
Creative Designer and Video Editor
K’awat’si Economic Development Corporation (KEDC)
Port Hardy, BC
- $55,000 to $60,000 CAD / year
- Full-time
…WordPress builder for our websites. You turn marketing ideas and content into finished art, build the pages, forms and templates the whole team uses, report to the Marketing Manager, and…
Added 1 hour ago
Y
Brand Ambassador - Marketing Events
YuJa
Toronto, ON · North York, ON
- $65,000 CAD / year
- Full-time
…camera, comfortable speaking and presenting, and has strong content creation and communication skills. Travel to conference venues, including international events, will be…
Added 1 hour 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 1 hour ago
TT
Senior Electrical Engineer
Tetra Tech
Pickering, ON
- Full-time
We are currently seeking a Senior Electrical and I/C Engineer for our Pickering/Mississauga, Ontario offices. This posting is for an existing vacancy for which we are actively recruiting.…
Added 2 hours ago
BC
Communication Assistant
Brant Community Healthcare System
Brantford, ON
- Full-time
Responsible for updating the BCHS website (webmaster) and helps to develop content for the BCHS Intranet.
Added 2 hours ago
Senior Program Manager - Corus FM Radio
Corus Entertainment
Toronto, ON
…and greatest value. Our mission is simple: to create engaging content, connect with audiences wherever they are, and drive meaningful…
Added 2 hours ago
Senior Digital Broadcast Journalist - Global National News
Corus Entertainment
Toronto, ON
…and greatest value. Our mission is simple: to create engaging content, connect with audiences wherever they are, and drive meaningful…
Added 2 hours ago
SM
RQ11856 – Training Specialist – Senior (Onsite)
S M Software Solutions Inc
Toronto, ON
- Internship
We are seeking a highly skilled Senior Training Specialist with extensive experience in digital learning development, instructional design, and technical training delivery. The ideal…
Added 2 hours ago
SM
RQ11733 – Business Analyst – Senior (Onsite)
S M Software Solutions Inc
Toronto, ON
- Internship
We are seeking a highly experienced Senior Business Analyst with strong expertise in stakeholder engagement, business analysis, organizational change management, training development, and…
Added 2 hours ago
SM
RQ11735 – Business Analyst – Senior (Onsite)
S M Software Solutions Inc
Toronto, ON
- Internship
We are seeking an experienced Senior Business Analyst with strong expertise in business analysis, stakeholder engagement, organizational change management, training development, and digital…
Added 2 hours ago
RI
Senior Digital Marketing Manager
RedRhino Inc.
London, ON
- Full-time
…technologies, and growth opportunities. This role is ideal for a senior digital marketing leader who thrives on variety, enjoys solving complex business problems, and wants to make a…
Added 2 hours ago
A
Senior DevSecOps Engineer
Aviso
Vancouver, BC
- $120,000 to $135,000 CAD / year
- Full-time
We're looking to fill an opening for a Senior DevSecOps Engineer to join our Technical Solution Partners (TSP) team.
Added 2 hours ago
ASSOCIATE SCIENTIST I - AGS
DiaSorin
Toronto, ON
…scientific experiments independently with supervision from senior members of the…
Added 3 hours ago
Associate VP
DEPT®
Toronto, ON
…partnering with the most ambitious enterprise clients, solving their content delivery challenges through implementing complex processes powered by industry leading proprietary…
Added 3 hours ago
MA
Sales Development Representative
Mosaic AI
Toronto, ON
- Full-time
Comfortable with senior buyers. You've called into mid-market and enterprise organizations and you know how a VP of Support thinks about headcount, backlog, and cost to serve. You don't get…
Added 3 hours ago
AA
Defence Sales Manager - Canada
Alta Ares
Ottawa / Toronto, .
- Full-time
Alta Ares is building its Canadian presence, and this is the first senior commercial hire on the ground. You will own Alta Ares’ business in Canada. You will set the strategy, build…

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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