Associate Director of Regulatory Affairs

Nexcella, Inc.; Toronto; On-site; CAD 120,000 - 180,000; Full time

Job summary

Nexcella, Inc. is seeking an Associate Director of Regulatory Affairs to drive regulatory strategy and execution for clinical trials under FDA/EMA/Health Canada/MHRA guidelines.

The role focuses on preparing, submitting, and maintaining regulatory documents with meticulous attention to detail and strong analytical skills. You will oversee IND filings, monitor regulatory changes, coordinate with internal teams and external partners, and support regulatory audits and inspections to ensure

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 3-5 years of experience in regulatory affairs within biopharma.
• Familiarity with FDA/EMA/Health Canada/MHRA regulations and submission requirements.
• Strong written and verbal communication, organization, and project management.

Responsibilities

• Assist in preparation, review, and submission of INDs, amendments, and filings.
• Monitor regulatory changes and communicate updates to teams.
• Coordinate with internal departments and external partners for submissions.
• Maintain records of regulatory correspondence and submissions.
• Support audits and inspections by regulators.

Skills

Regulatory knowledge

Attention to detail

Analytical skills

Project management

Communication

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

eCTD submissions

Regulatory software tools

Job description

Associate Director of Regulatory Affairs

Our 3 Core Values

• Integrity
• Initiative

What You’ll Do

The Director of Regulatory Affairs will support the regulatory strategy and execution for clinical trials conducted under FDA/EMA/Other Regulatory agencies regulations. This role is responsible for preparing, submitting, and maintaining regulatory documents and ensuring compliance with all applicable laws and guidelines. The ideal candidate will demonstrate strong attention to detail, analytical skills, and knowledge of FDA/EMA/HealthCanada/MHRA requirements for investigational products.

Key Responsibilities

• Assist in the preparation, review, and submission of INDs, amendments, and other regulatory filings.
• Monitor regulatory changes and communicate updates to relevant teams to ensure ongoing compliance.
• Coordinate with internal departments and external partners to gather necessary documentation for regulatory submissions.
• Maintain accurate records of regulatory correspondence and submissions.
• Support audits and inspections by regulatory authorities.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred.
• 3-5 years of experience in regulatory affairs within the biopharmaceutical industry.
• Familiarity with FDA/EMA/HealthCanada/MHRA regulations, clinical trial processes, and regulatory submission requirements.
• Strong written and verbal communication skills.
• Excellent organizational and project management abilities.

Preferred Skills

• Familiarity with eCTD submissions and regulatory software tools.
• Ability to work effectively in a collaborative, fast-paced environment.
• Attention to detail and analytical problem-solving skills.

Nexcella, Inc. is a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a proprietary CD3ζ, CD8 hinge and binder “digital filter” designed to filter out non‑specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a potentially registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at www.nexcella.com and www.BeProactiveInAL.com.