Regulatory Affairs Director

6 days ago

Seattle, Washington, United States Umoja Biopharma Full time
Job Title: Director, Regulatory Affairs

Umoja Biopharma is a pioneering biotech company dedicated to revolutionizing cancer treatment with its innovative integrated immunotherapy platform. Our mission is to develop off-the-shelf therapies capable of treating any tumor, at any time. We are a diverse and growing team working in state-of-the-art facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are seeking innovative thinkers who are passionate about groundbreaking science and technology, and committed to the principles of Diversity Equity and Inclusion.

Job Summary

The Director, Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Nonclinical and Clinical Modules for regulatory submissions to support Umoja's drug products, including DMF, IND, and NDA/BLA applications, Health Authority responses, and briefing packages. In this role, the Director will represent Regulatory Affairs on technical teams, participate in internal development teams, and interface with external contractors/consultants.

Key Responsibilities
  • Provide strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for development projects.
  • Plan, prepare, and manage submissions to Health Authorities, including DMFs, INDs, NDA/BLA, and CTD regulatory filings.
  • Lead regulatory interactions with Health Authorities, including managing preparation of briefing materials for HA meetings, preparing subject matter experts, and ensuring appropriate follow-up.
  • Work in close collaboration with consultants and/or CROs, as needed, to ensure appropriate interactions with Health Authorities.
  • Represent the regulatory function on cross-functional product development teams and provide innovative strategic and tactical advice to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
  • Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Regulatory Affairs, program teams, senior management, and external stakeholders.
  • Identify, communicate, and propose resolutions to both routine and complex issues.
  • Deliver clear and engaging presentations to internal teams and senior management.
  • Remain current on Regulatory Intelligence, new guidance documents, and competitive information to provide comprehensive information to program teams.
  • Support or lead non-project activities, as needed, such as SOP/standards development.
Requirements
  • BS/BA degree (or equivalent) in a relevant scientific field required; advanced degree (MS or PhD) is preferred.
  • A minimum of 10 years of experience in regulatory affairs with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry is a must, including 3 years of experience in management/leadership roles.
Preferred Qualifications
  • Experience with oncology products.
  • Knowledge of regulatory requirements across development stages and post-approval is essential. Experience with regulations for biologics and/or small molecules required, cell/gene therapy desired, and combination products desired.
  • Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.
  • Strong strategic and analytical abilities, diplomacy, and negotiation skills.
  • Ability to collaboratively influence across multiple functions, and motivate others to accomplish company objectives.
  • Ability to work flexibly within tight timelines and with strong project management skills.
  • Self-motivated and detail-oriented with sound judgment and innovative thinking to deal with challenges/opportunities.
Physical Requirements
  • This role can be based anywhere in the US, with a preference for the Seattle area.
  • Ability to travel occasionally.
Salary Range

$195,500 - $237,000

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

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