Associate Director of Regulatory Operations

Our Culture: Why work with us?  

Our most valuable resource is our people–with a diversity of backgrounds, ideas, opinions, and life experiences. There’s a dedication to one another that’s palpable. We hire kind, smart, creative, passionate professionals who are always learning and teaching. We’re incredibly proud that as we’ve grown, our vibrant culture has remained steadfast. We continue to build a culture of collective hard work without egos. Leaders are transparent, accessible, honest, authentic, and invest in their employees. “We’re all in this together,” is our company’s mission.

Our Science:

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life.  We have a robust pipeline with clinical assets in phase 1, 2 and 3 for the treatment of prostate, brain, lung, and pancreatic cancers. Candel is a newly public company having completed its IPO at the end of July 2021. Please visit www.candeltx.com for additional information.

What’s in it for you:

  • Establish submission TOCs with Regulatory strategists and cross-functional teams
  • Serve as a Regulatory point of contact for distribution of eCTD document templates to project teams
  • Establish and track timelines with cross-functional teams for the orderly and efficient review, finalization and publishing of documents to be submitted to regulatory authorities
  • Track global submission activities at the document level and regularly report progress and challenges to project teams and senior management
  • Assess with Regulatory strategy and operations submission and health-authority activity for the purpose of resource planning
  • Provide expertise in all aspects of formatting, publishing, version and quality control of Word and PDF documents during draft and final document team reviews
  • Manage the publishing and submission activities of US and European product applications
  • Ensure documents adhere to appropriate external regulatory guidelines and comply with company style guides and SOPs
  • Catalog and maintain in RIMS Regulatory submissions, correspondence and agency commitments to ensure reliability and traceability of Regulatory documentation
  • Provide periodic metrics and reports to senior management and other stakeholders in support of research, audit or inspection activities

 What we’ll need from you:

  • Minimum 8-10 years of progressive Regulatory Operations experience
  • Strong knowledge of US and ex-US regulations and guidances governing product submissions and eCTD structuring, preferable within an oncology environment
  • Experience with ex-US submissions, particularly to European and Canadian health authorities
  • Hands-on experience in formatting and pre-publishing documents pertaining to initial applications; clinical, CMC and nonclinical amendments; safety notices and annual reports
  • Ability to track and report on documents through their development, review and signoff phases across multiple submission projects
  • Ease in working within in a team-matrix environment to anticipate needs and coordinate activities with other team members.
  • Experience and comfort with managing direct reports and/or contractors
  • Familiarity with regulatory technical systems such as RIMS and EDMS
  • Expertise in MS Word, Adobe and at least one document-template product
  • Effective skills in communicating orally and in writing
  • Ability to perform well under pressure and to work proactively with teams to minimize pressure points

Corporate Culture:

A fundamental belief held by the Candel Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large.  Please visit www.candeltx.com for more information.

We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology.  For consideration, please submit CV.

Interested candidates please submit your resume to careers@candeltx.com