Submission Manager, Regulatory Operations (Life Sciences)

Location: Warsaw, Poland; 70% in-office work model

Company

hirify.global develops mRNA medicines and operates a global biotechnology platform focused on transforming medicine.

What you will do

• Plan, manage, and track submission content from authoring and approval through publishing, quality control, and delivery to health authorities.
• Provide regulatory operations expertise for global submissions, including INDs, NDAs, MAAs, updates, amendments, and variations.
• Coordinate cross-functional teams, Regulatory Leads, CRO partners, publishing vendors, health authorities, and other stakeholders.
• Oversee submission planning, preparation, publishing, validation, lifecycle information, and delivery within required timelines.
• Act as a subject matter expert for electronic submission formats, lifecycle management, and the document management system.
• Use document formatting, troubleshooting, presentation, and emerging Generative AI capabilities to improve submission efficiency while maintaining compliance and human oversight.

Requirements

• Bachelor's degree in a scientific discipline, systems technology, or equivalent.
• 5–8 years of pharmaceutical experience in a regulated life science environment.
• Advanced knowledge of eCTD publishing systems, EDMS technology, and related publishing tools.
• Extensive knowledge of FDA, Health Canada, EMA, ICH, eCTD, and global submission standards, including INDs and CTAs.
• Knowledge of CDISC standards, including ADaM, SEND, and SDTM, plus strong MS Word, PDF Professional, and PowerPoint skills.
• Proficiency in English is required for global collaboration.

Culture & Benefits

• In-person collaboration supported through a 70/30 work model.
• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, and broader well-being support.
• Family-building benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, bank holidays, volunteer days, sabbatical, recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific benefits.