Associate Director, CMC Regulatory Affairs

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. 

We are looking for an Associate Director, CMC Regulatory Affairs (RA) who will work closely with our manufacturing and quality teams to develop and implement global CMC strategies for multiple biologics programs, from pre-clinical through Phase 3 studies. You will be a key member of project teams, shaping the CMC RA strategy and documentation for innovative new biologics and ensuring submissions are aligned with health authority requirements and delivered on time with quality.

How you might spend your days:

• Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies 
• Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings 
• Overseeing the preparation of responses to regulatory authority queries
• Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams 
• 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
• Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
• Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
• Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines 

We'd love to hear from you if:

• You have a deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
• You can seamlessly navigate regulatory requirements for CMC submissions for biologics and combination products, and look forward to the preparation of regulatory submissions
• You have a thorough understanding of Health Canada, FDA, and EMA regulations 
• You can efficiently oversee independent contractors and vendors
• You are a skilled regulatory 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 have a relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field, plus about 12 years of relevant work experience

What we offer:

AbCellera’s hiring range for this role is CAD $141,000 - $170,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team 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 23350 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.