Senior Manager, Regulatory Operations

Location: Princeton, New Jersey, United States

Salary: $150,034–$224,250 per year, plus incentive opportunity.

Company

hirify.global is a pharmaceutical company developing and commercializing healthcare products.

What you will do

• Coordinate regulatory publishing and electronic submission deliverables across R&D functions.
• Own the delivery, quality, timelines, and archival of electronic regulatory submissions.
• Coordinate content publishing with affiliates and collaborate with alliance partners on shared dossiers.
• Design and implement processes and systems for electronic lifecycle and maintenance submissions.
• Supervise staff and vendor partners performing document quality-control checks and submission activities.
• Lead process-mapping initiatives and maintain regulatory operations work instructions and files.

Requirements

• Minimum 7 years of regulatory operations experience with hands-on electronic application submissions.
• Expertise in eCTD formatting, publishing, submission, lifecycle management, and archiving.
• Knowledge of FDA, EMA, Health Canada, and Swissmedic regulations and guidance for electronic and paper submissions.
• Recent experience with NDAs and MAAs.
• Expert knowledge of document management systems, preferably Documentum, and regulatory publishing tools.
• Strong Microsoft Office and SharePoint skills, with experience developing technology-enabled processes across departments.

Nice to have

• Staff management, outsourcing, and project management experience.
• Regulatory affairs certification, such as RAPS certification.
• Experience working in a global, matrixed, multicultural environment.
• Strong influencing, communication, and innovative problem-solving skills.

Culture & Benefits

• Collaborative work with colleagues, affiliates, alliance partners, and cross-functional stakeholders.
• Medical, dental, vision, and prescription drug coverage.
• Company-provided life and disability insurance.
• Tuition reimbursement, student loan assistance, and a generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.