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Senior Manager, Regulatory Affairs

1 month, 3 weeks ago
United States
Full-time
Senior
Operations Manager
Operations
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 20

Description

  • Lead and coordinate interactions with project teams, clinical study teams, management, consultants, and collaborators to support timely regulatory submissions.
  • Oversee preparation and completion of submission documentation for FDA and ex-U.S. regulatory agencies.
  • Support data collection, cross-functional authorship, proofreading, editing, and assembly of regulatory documents.
  • Communicate submission timelines across teams and follow up to keep deliverables on schedule.
  • Serve as the primary interface with regulatory publishing to ensure compliant electronic submissions.
  • Archive and maintain regulatory submissions and correspondence in the regulatory information management system.
  • Implement standardized templates and documentation guidelines and provide formatting support to team members.
  • With guidance from regulatory leadership, interpret and communicate U.S. and international regulatory requirements.
  • Support global regulatory leads on clinical study and execution teams to help meet trial deliverables, timelines, and objectives.

Requirements

  • BS, MS, PhD, or equivalent in regulatory affairs or a related scientific discipline.
  • Regulatory Affairs Certification (RAC) credential preferred.
  • Minimum of 5 years of regulatory experience in drug development within the biopharmaceutical industry.
  • Experience interacting with health authorities, including FDA and EMA.
  • Strong project management skills with a high sense of urgency and the ability to collaborate and influence cross-functionally.
  • Strong communication skills with the ability to present to diverse stakeholders and tailor messaging appropriately.
  • Experience with Veeva Regulatory Information Management (RIM) platforms, eCTD submissions, and Microsoft Office SharePoint/Teams.
  • Ability to exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.
  • Position requires up to 10% travel, including mandatory in-person attendance at All Hands meetings typically held twice per year.

Benefits

  • Anticipated salary range of $155,000 to $175,000.
  • Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Resources and support for professional development.
  • Opportunity to work in a fast-paced, highly dynamic environment.
  • 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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