POSITION 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 (HA) responses, and briefing packages (including participating in/leading HA meetings). In this role, the Director will represent Regulatory Affairs on the technical teams, participate in internal development team(s), and interface with external contractors/consultants.

This key role will develop and implement regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and unmet needs. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.

CORE ACCOUNTABILITIES

Specific responsibilities include:

• Independently provide effective phase-appropriate 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 HAs including DMFs, INDs, NDA/BLA and CTD regulatory filings
• Lead regulatory interactions with HAs including managing preparation of briefing materials for HA meetings, preparing subject matter experts (SMEs), and ensuring appropriate follow-up. 
• Work in close collaboration with consultants and/or CROs, as needed, to ensure appropriate interactions with HAs.
• Utilize various electronic systems for dossier creation and tracking
• 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 (as relevant)
• 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

The successful candidate will have:

• 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.
• 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 judgement 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