Reports to: Vice President, Research & Development
Location: Office in Washington, DC; Option to Work Remotely in US Only

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization.

Position Summary:

The Sabin Vaccine Institute (Sabin) is seeking a Regulatory Affairs Manager with in-depth experience in Regulatory Affairs to join its Vaccine Research & Development (R&D) Team. The incumbent will work with the non-clinical and clinical teams to support Sabin’s product development activities with responsibilities including regulatory document writing, editing and review. The role will provide key technical and regulatory affairs support to advance the vaccine pipeline and requires experience in immunobridging under the FDA Animal Rule. The Senior Manager will collaborate with cross-functional internal teams and outside contract labs to drive vaccine candidates through licensure.

Responsibilities:

Research Science

  • Support compliance and data reporting objectives across clinical and non-clinical vaccine R&D projects by completing action items, reviewing minutes and/or facilitating audits
  • In conjunction with the supervisor and R&D team, devise plans that support the overall product development strategy with a focus on successful immunobridging data acquisition and analysis
  • Present R&D findings to internal Sabin audiences to promote efficient project planning that integrates scientific and regulatory aims
  • Manage regulatory information flow between internal and external stakeholders
  • Support data review of product specific assays (ELISA, Ad-neut, PsVNA, stability), bioanalytical (SDS-PAGE, SEC, W. blot) methods and PK/PD data analysis and reports
  • Participate in the planning and review of non-human primate studies designed to address the safety and efficacy of vaccine candidates

Regulatory Affairs

  • Participate in regulatory projects as assigned to facilitate best practice approaches
  • Support regulatory review of assay development and non-clinical/CMC data that will be included in regulatory submissions including, but not limited to new INDs, Annual Reports and Protocols
  • Collaborate with external partners to draft, review and approve new regulatory submissions and updates
  • Coordinate the maintenance of regulatory work process tools to promote efficiency and productivity (these may include templates, SOPs, work instructions, checklists, trackers, etc.)
  • Perform literature searches and attend webinars and meetings to stay abreast of regulatory policy changes and evolving practices
  • Ensure that records are complete and accurate and follow current guidelines depending on the country and filing (e.g., cGMP, cGCLP, and recordkeeping guidance published by international counterparts of the U.S. FDA) 
  • Lead Sabin’s regulatory strategy under the Animal Rule
  • Analyze, interpret, and summarize complex scientific data for presentation to management and regulatory agencies

Organizational Management

  • Work with project management to identify regulatory risks, and mitigate/resolve issues
  • Coordinate regulatory goals across clinical and non-clinical teams to ensure harmonization and knowledge sharing
  • Manage external contacts, including global regulatory agencies, corporate partners, standards setting groups, and industrial colleagues
  • Identify regulatory risks and provide contingency plans to mitigate them
  • Influence scientists to consider the regulatory implications of their experiments and where appropriate to present data in direct support of regulatory objectives  

Required Skills

  • Bachelor’s degree in a related scientific field (e.g., biology, biochemistry, immunology, veterinary and animal sciences); advanced degree such as master’s preferred
  • 9+ years relevant scientific and FDA-regulatory experience preferably with focus on development of vaccines or immune-based therapies in the biopharmaceutical or biotech industries; regulatory affairs certification or similar formal training is highly desirable
  • Proven experience with U.S. Government-funded vaccine R&D (e.g., WRAIR, DARPA, BARDA, NIH/NIAID)
  • Experience with compliance for pre-clinical studies and IACUC Submissions (preferred)
  • Held a position that required Public Trust Security Clearance for the review of confidential regulatory filings and can obtain this level of clearance
  • Proven experience with FDA Animal Rule submissions
  • Demonstrated expertise in addressing animal use issues (IACUC) and Accelerated Approval regulatory pathways (preferred)
  • Knowledge of pre-clinical development (animal studies) and an understanding of its foundational importance to clinical development
  • Experience with GLP and non-GLP assays and data analysis; GMP assay development experience at a Contract Manufacturing is desirable
  • Proven experience designing/reviewing biological safety level 2 (BL2) studies and the ability to assist with work that reaches to BL4 as needed
  • Understand what motivates others and build this into mentoring strategies
  • Strong attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing objectives to meet deadlines
  • Demonstrated ability to operate with purpose, urgency and accuracy in a fast-paced and deadline-driven environment
  • Ability to travel with notice

Other:

  • Subject to a criminal background investigation
  • Request for three professional references
  • Verification of education/degrees

Attributes that Are Important to Sabin:

  • Diversity, Equity and Inclusion
  • Problem-Solving and Critical Thinking
  • Decision-Making
  • Communication and Professionalism
  • Initiative and Ownership
  • Productivity and Quality Control
  • Professional Development/Personal Learning

How to Apply:

To be considered, please submit your cover letter and resume via e-mail to [email protected]. Please be sure to reference “Regulatory Affairs Manager-R&D” in the subject line. Your cover letter should: (1) address the reasons for your interest in this position, and; (2) describe the knowledge, skills and abilities you would bring the Sabin Vaccine Institute. No phone calls, please. Only short-listed candidates will be contacted.

Salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package.

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.