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Senior Manager, Regulatory Affairs Project Management

3 hours, 32 minutes 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 5

Description

  • Develop and manage complex regulatory project plans to support submission activities across multiple regions.
  • Track timelines, deliverables, and milestones for IND, CTA, BLA, NDA, and MAA submissions.
  • Coordinate responses to regulatory queries and correspondence with subject matter experts.
  • Translate regulatory strategy into actionable cross-functional project plans and keep activities on schedule.
  • Organize and facilitate cross-functional meetings to drive alignment and accountability among stakeholders.
  • Monitor CTA and IND submission status across assigned projects.
  • Support strategic planning and risk mitigation, including portfolio-level analysis to identify resource bottlenecks.
  • Evaluate, implement, and improve project management tools and reporting frameworks, especially Smartsheet.
  • Design and maintain Smartsheet sheets, reports, dashboards, and forms connected to regulatory activities.
  • Troubleshoot PMO solutions and contribute to system updates, new capabilities, and process improvements.

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, or MAA submissions required.
  • Familiarity with CRO operations and global regulatory requirements for clinical trial applications.
  • Experience supporting global interventional clinical studies and CTA submissions.
  • Hands-on Smartsheet experience; Smartsheet Core Product Certification or equivalent desirable.
  • Proficiency with project management tools including 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.
  • A proactive, structured approach to problem-solving with the ability to think cross-functionally and convert ideas into actionable plans.
  • Ability to work independently and thrive in a dynamic environment.
  • Willingness to travel up to 20%, including mandatory in-person attendance at twice-yearly All-Hands meetings and trips to San Francisco and/or Boston.

Benefits

  • Anticipated salary range of $150,000 to $170,000.
  • Market-competitive compensation package with 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.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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