Vor Bio

Vor Bio

Director/ Senior Director, Regulatory CMC

Boston, MA · Director

Sponsorship not specifiedDetected 2 days ago
Product ManagementFDA RegulatoryMedical DevicesResearchCommunicationCollaborationCritical Thinking

About the role

  • When you join Vor, you're not just working on a medicine.
  • Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.
  • Vor Bio is seeking an exceptional and highly motivated CMC leader Director/Sr Director Regulatory CMC to join our team.

Responsibilities

  • As a member of the CMC project teams, act as Regulatory CMC Lead for assigned programs providing strategic guidance to development team(s) on complex regulatory CMC topics.
  • Provide regulatory strategic and tactical support for CMC aspects such as change control & inspection management.
  • Maintain responsibility for all CMC Regulatory timelines, that also includes managing contract staff and vendors relevant to CMC activities.
  • Build and maintain strong relationships with internal and external stakeholders.

Requirements

  • Strong scientific background and training in manufacturing processes and development and development of combination biologic/device products are required.
  • A strong background & track record in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of biologic medicinal products.
  • Strong understanding of the global pharmaceutical drug development and regulatory environment, including anticipating future trends and opportunities in biologics.
  • Ability to interact effectively across all levels of the organizations
  • integrates functional expertise with business knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives.
  • Strong oral and written communication skills with strong attention to detail and the ability to coordinate multiple activities in a faced paced biotech environment.
  • We invite you to come as you are.
  • The candidate must be a highly effective leader as they will be relied upon to drive robust CMC strategic plans throughout development.
  • This individual should also have strong interpersonal skills and a demonstrated track record with regulatory agencies.
  • Extensive experience in the development of biologics and combination biologic/device products is a must.

Skills

  • PharmD or PhD preferred with ≥8 years of industry experience in Regulatory CMC biologics.
  • Small molecule and medical device experience are a plus.
  • Experience working with FDA sCDER is required.
  • Experience interfacing with FDA, and other global health authorities.
  • Demonstrated risk identification and critical thinking skills.
  • Recognized as an influential leader who possesses a cross-functional collaborative skill set.

Compensation

  • The salary range for the Director, Regulatory CMC is expected to be between $200,000 and $220,000 per year.

Company info

  • Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.
  • At Vor, we believe science can do more than manage symptoms.
  • By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades.
  • Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.
  • You're part of a mission to redefine the future of autoimmune care.
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