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Director, Regulatory Affairs

All Openings | Research Triangle Park, NC | Full Time

Job Description

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  We are currently developing multiple vascular tissue engineered therapies and expanding our business model.  With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.  We are looking for additional biomedical research and development colleagues to continue to build our expanding team.

Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

Reporting to the Chief Regulatory Officer (CRO), the Director of Regulatory Affairs will be responsible for partnering with the CRO in developing and leading all regulatory strategies and activities for Humacyte, including all regulatory submissions.  This includes ensuring that all of Humacyte’s regulatory goals are met, and in compliance with all current industry standards globally.  This role will manage internal Regulatory staff, oversee third party Regulatory service providers, and will be a key member of the Regulatory leadership team.

KEY RESPONSIBILITIES:

  • Contribute to the development and implementation of pre-clinical, clinical, CMC, regulatory strategy for projects in all stages of development (pre-BLA through BLA)
  • Works cross-functionally with internal departments, including clinical, quality, manufacturing, and third parties on Regulatory Affairs related issues
  • Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities
  • Defines strategies for, coordinate the execution of, and ensure the proper archival of regulatory submissions including clinical trial applications; Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License (BLA) Applications and Marketing Authorization Approvals (MAAs)
  • Interpret FDA (and other regulatory body) communications, expectations and decisions to internal and external stakeholders (including CRO’s, CMO’s, consultants and contractors), developing and implementing successful issue resolution strategies
  • Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities, including meeting requests, briefing packages, and fast track applications
  • Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
  • Contribute to the creation of the combination product strategy and manage the development, monitoring and delivery of integrated project plans throughout the lifecycle of development of combination product development
  • Manage the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
  • Identify and assess regulatory risks projects or programs
  • Present operational plans, scientific data and strategy to internal and external audiences, including regulators, key opinion leaders, partners, and executives
  • Advise senior management of the impact the changing regulatory environment can/will have on Humacyte’s business and projects
  • Support post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials
  • Responsible for cost-effective management of Regulatory Affairs department budget
  • Responsible for departmental resources, including recruitment, deployment, professional development and management of regulatory staff
  • Maintain, create relevant SOPs, Work Instructions and other necessary guidance
  • Other duties, as assigned

General Competencies:

  • Possess a positive attitude and optimistic outlook
  • Motivated and organized critical thinker with solid interpersonal and business communication skills
  • Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results
  • Routinely communicate and present findings and information to other team members; transparency and knowledge sharing is expected and practiced
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Detail-oriented, self-motivated and scientifically driven
  • Strong analytical and problem solving skills
  • Demonstrated ability to work in a cross functional team
  • Strong written and oral communication skills

Special Competencies:

  • Proven excellence in operational strategy
  • Ability to interpret, communicate, and present regulatory information in a clear and concise manner
  • Demonstrated ability to proactively and effectively influence peers and external colleagues across all levels of management
  • Proven negotiation skills
  • Self-starter, independent and a practical thinker

QUALIFICATIONS:

  • PhD strongly desired with focus in Pharmaceutical Sciences or a technical field preferred.  Will consider minimum BS or a MS degree holders:
    1. 18+(BS), 15+(MS), 10+(PhD) years of relevant and current work experience in the fields of Regulatory Affairs, Product Development, and/or Clinical Operations
  • Credentials (RAC, other) through RAPS or other professional society highly desirable
  • 5+ years of demonstrated success in regulatory team leadership role and proven management by influence
  • Direct experience with FDA and international agencies required
  • Solid understanding of dossier requirements Biologics License (BLA) Applications, New Drug Application (NDA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD, CTA)
  • Knowledge of regulations and regulatory process in all global markets

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies
  • Career Development and Training


**Please note, Humacyte does not provide sponsorship at this time.**