Sr. Manager, GRS Integration (Biotech)

Location: Cambridge, Massachusetts, United States; 70% in-office under a 70/30 work model. Only U.S. persons are eligible due to U.S. export control requirements.

Salary: $130,800–$209,400 per year, with potential bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA technology and medicines through a biotechnology platform focused on scientific and medical innovation.

What you will do

• Support one or more development and marketed programs within Global Regulatory Science.
• Develop and maintain integrated regulatory plans covering milestones, deliverables, timelines, dependencies, and ownership.
• Manage regulatory trackers, dashboards, planning tools, risks, and upcoming decision points.
• Facilitate regulatory team meetings and coordinate decisions, actions, and follow-up activities.
• Support submissions, health authority interactions, responses to questions, CMC activities, variations, and country-specific requirements.
• Improve regulatory planning processes, tools, data quality, visibility, and operational consistency.

Requirements

• BA/BS degree in a scientific, engineering, healthcare, business, or related discipline.
• At least 5 years of progressive experience in pharmaceuticals, biotechnology, life sciences, regulatory project or program management, regulatory operations, or drug development.
• Experience with regulatory planning and execution across development, registration, or post-marketing activities.
• Knowledge of U.S. regulatory requirements, international regulatory requirements, regulatory submissions, regulatory documentation, and eCTD processes.
• Strong project management, organization, facilitation, communication, influencing, risk management, and prioritization skills.
• Must qualify as a U.S. person; visa sponsorship for non-U.S. persons is not available for this position.

Nice to have

• Advanced degree or project management certification.
• Experience with technology and tools that improve regulatory planning, visibility, and execution.

Culture & Benefits

• In-person collaboration model with direct mentorship and teamwork.
• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off including vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs plus location-specific benefits.