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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
KE
Content Specialist
K’awat’si Economic Development Corporation (KEDC)
Port Hardy, BC
- $65,000 to $70,000 CAD / year
- Full-time
KEDC (K'awat'si Economic Development Corporation), KEDC is an Indigenous-owned business. Interest in, and respect for, First Nations culture and practice is a core part of our mandate and…
Added 13 mins 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
KEDC (K'awat'si Economic Development Corporation), KEDC is an Indigenous-owned business. Interest in, and respect for, First Nations culture and practice is a core part of our mandate and…
Added 13 mins ago
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Generalist, Human Resources
Gordon Food Service - Canada
Milton, ON
- Full-time
…affirmative action and employment compliance. Works closely with senior HR management to provide services for a designated geographic region and shared…
Added 13 mins ago
HR
Logistics Manager
Horizon Recruitment Inc
Vancouver, BC · Greater Vancouver, BC
- $115,000 to $125,000 CAD / year
- Full-time
Horizon Recruitment is recruiting for a Logistics Manager to lead transportation operations for a well established organisation serving businesses across Western Canada.
Added 14 mins ago
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Wealth Operations Analyst I
TD
Toronto, ON
- Full-time
…opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been…
Added 14 mins ago
Vice President of Operations
Northern911
Sudbury, ON
Foster a culture where people want to stay and grow, through engagement, recognition, and leadership development that strengthens retention and empowers your team members, and where…
Added 14 mins ago
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Senior Joint Venture Representative
Keyera
Calgary, AB
- Full-time
Keyera is seeking a Senior Joint Venture Representative to join our Facility Contracts team. Reporting to the Manager, Facility Contracts, this role serves as the primary steward for a…
Added 14 mins ago
Senior Financial Analyst
Trisura Guarantee Insurance Company
Toronto, ON
Reporting to the Manager, Finance, the Senior Financial Analyst will play a key role in regulatory, reinsurance and financial reporting. The position will be responsible for preparing the…
Added 14 mins ago
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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
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Bilingual Operations Manager (EN/FR)
BGIS
Montreal, QC
- Full-time
The Manager, Operations is responsible for operations and budget management, service delivery management, project management, client relationship management, health and safety, and…
Added 14 mins ago
Senior Associate, OOH Solutions
WPP Media
Toronto, ON
In this role you will be responsible for the development of OOH and print campaigns across a variety of WPP Canada clients. We are seeking someone who has a point of view to drive holistic…
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
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Assessor Coordinator Degree
HealthCareersInSask.ca
Swift Current, SK
- Full-time
…including but not limited to nursing, psychology, management, senior staff to triage acute medical, mental health, and detoxification concerns. The incumbent will work in collaboration with…
Added 14 mins ago
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Senior Manager, Insurance Finance
BMO
Toronto, ON · YNG
- Full-time
Senior Manager, Insurance Finance, is a high-impact leadership opportunity for a CPA-designated finance professional with strong controllership experience and a proven ability to develop…
Added 28 mins ago
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Senior Manager, Workplace & Travel
AIMCo
AB · Calgary, AB
- Full-time
At AIMCo, a great workplace is a key enabler of our people and our investment success. As Senior Manager, Workplace & Travel, you will lead our workplace experience, facilities, corporate…
Added 28 mins ago
LC
Life Enrichment Worker_FT-Perm
LOFT Community Services
Toronto, ON
- $52,022 to $61,821 CAD / year
- Full-time
…to The Path Home – Pine Villa, you will meet with your case manager to review what you hope to achieve while you are living at Pine Villa. These could include - health and wellness goals,…
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 28 mins ago
GF
Generalist, Human Resources
Gordon Food Service
Milton, ON
- Full-time
…affirmative action and employment compliance. Works closely with senior HR management to provide services for a designated geographic region and shared…
Added 43 mins ago
TE
Director of Condominium Management
The Enfield Group Inc
Burlington, ON
- Full-time
The Director of Condominium Management leads Enfield's condominium management division. The role oversees three Senior Property Managers and a Property Manager Assistant, and builds out the…
Added 43 mins ago
S
Music Therapist
St.Amant
Winnipeg, MB
- Full-time
…paramount to supporting the community we serve. Reporting to the Senior Manager, Clinical Services and consistent with the Mission, Values and policies of St.Amant, the Music Therapist is a…
Added 43 mins ago
Physiotherapist - Rehabilitation & Supportive Care Services
Nova Scotia Health and IWK Health
Dartmouth, NS
The physiotherapist works under the supervision of a CZ Manager and is a member of the interdisciplinary Seniors Care Team responsible for providing service to seniors >65 years of age in…
Added 43 mins ago
Reporting Analyst
Aecon
Pickering, ON
Are intentional when it comes to investing in your development. We help you build your career and advance your skills through our Aecon University, tuition reimbursement, and Leadership…
Added 58 mins ago
AP
Senior Manufacturing Systems Engineer
Atlantic Packaging Products Ltd.
Toronto, ON · Scarborough, ON
- Full-time
The Senior Manufacturing Systems Engineer provides technical leadership across manufacturing operations, process optimization, reliability improvement, capital planning, and operational…
Added 58 mins ago
Senior Product Manager, AV Solutions and Ecosystems
Nureva
Ottawa, ON · Kanata, Ontario
We are looking for a Senior Product Manager to define how Nureva's audio technology becomes part of complete, compelling AV solutions for corporate and enterprise spaces.

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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