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Senior Manager, Regulatory Affairs Project Management

4 weeks ago
United States
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 22

Description

  • Optimize planning, execution, and tracking of development-stage global regulatory activities.
  • Coordinate timelines and deliverables for regulatory submissions including IND, CTA, BLA, NDA, and MAA activities.
  • Translate regulatory strategy into actionable project plans and keep cross-functional work on schedule.
  • Organize and facilitate cross-functional meetings to align stakeholders and track submission progress.
  • Monitor CTA and IND submission status across assigned projects.
  • Support risk mitigation, portfolio-level analysis, and identification of resource bottlenecks across programs and studies.
  • Evaluate, implement, and support project management tools and reporting frameworks, especially Smartsheet.
  • Design and maintain Smartsheet sheets, reports, dashboards, and forms tied to regulatory activities.
  • Troubleshoot and improve PMO solutions, including system updates and new capabilities.
  • Contribute to regulatory strategy and continuous improvement of project management practices.

Requirements

  • Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.
  • 5+ years of experience, including 3+ years of project management experience in the pharmaceutical or biotech industry preferred.
  • Experience planning IND and CTA regulatory submissions required.
  • Familiarity with the components of regulatory submissions required.
  • Experience planning BLA, NDA, and MAA submissions required.
  • Experience with CRO operations and global regulatory requirements for clinical trial applications preferred.
  • Experience supporting global interventional clinical studies and CTA submissions preferred.
  • Hands-on Smartsheet experience required; Smartsheet Core Product Certification or equivalent is desirable.
  • Proficiency with project management tools such as Smartsheet, ThinkCell, PowerPoint, Excel, SharePoint, and Office Timeline Pro.
  • Familiarity with regulatory systems such as Veeva RIM preferred.
  • Knowledge of biotech processes, scientific terminology, and drug development concepts.
  • Strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities and deadlines.
  • Ability to work independently and thrive in a dynamic environment.
  • Up to 20% travel required, including twice-yearly in-person All-Hands meetings and frequent travel to San Francisco and/or Boston.

Benefits

  • Anticipated salary range of $150,000 to $170,000.
  • Market-competitive compensation and benefits package, including base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to resources for growth.
  • Opportunity to work in a fast-paced, highly dynamic environment with regular in-person team meetings.

Interested in this position?

Apply directly on the company website

Apply Now

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