GRA CMC Lead (Vaccines)

Location: Toronto, ON, Canada; onsite

Salary: CAD 108,900–157,300 per year

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines based on immunoscience.

What you will do

• Develop global CMC regulatory strategies for vaccine development projects and marketed products.
• Assess regulatory and financial risks, participate in change control assessments, and resolve CMC regulatory issues.
• Coordinate CMC regulatory submissions, variation files, supporting documents, and post-approval commitments.
• Manage responses to Health Authority requests and build relationships with global regulators.
• Support strategic negotiations with the FDA and EMA and contribute to regulatory inspections when applicable.
• Collaborate with Global and Regional Regulatory Affairs, R&D, Industrial Affairs, quality, legal, finance, and external partners.

Requirements

• BS/BA degree in Biology, Chemistry, Life Sciences, or a related scientific discipline.
• At least 4 years of experience in a regulatory role, preferably in the pharmaceutical industry.
• Knowledge of global regulations, guidelines, Health Authorities, and their operating models.
• Ability to solve strategic technical and regulatory problems and communicate effectively with internal and external partners.
• Operational experience in a medium-to-large Regulatory CMC organization is preferred.
• An advanced degree such as PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or a related field is preferred.

Culture & Benefits

• Supportive, future-focused R&D environment centered on immunoscience and scientific innovation.
• Opportunities for career growth through promotion or lateral and international moves.
• Employee rewards and benefits programs.
• Healthcare, prevention, and wellness benefits for employees and families.
• Equal opportunity workplace with accommodations available during recruitment.