Associate Director Regulatory Affairs

Our Culture: Why work with us?  

We value the diversity of backgrounds, ideas, opinions, and life experiences that our team members bring to Candel. There’s a dedication to one another that’s palpable. We hire kind, smart, creative, trusting, passionate professionals who are always learning, and teaching and putting the patient first.  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, instilling mutual trust and accountability. Our Leaders are accessible, authentic, and invest in their employees.  We believe in giving team members freedom with accountability”, meaning our focus is on results, not where and when employees work. “We’re all in this together,” is our company motto.

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.

A day in the life of this role:

  • Support Global Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
  • Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports
  • Provide operational and authoring support on strategic regulatory documents to help drive timely deliverables
  • Drive operational excellence in Global Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency
  • Additional responsibilities, in conjunction with regional and/or global regulatory leads, include:
  • IND, BLA, and sBLA maintenance submissions
  • Safety and Annual report submissions (regulatory components)
  • Coordinating and driving rapid response team meetings to ensure quality and timely responses to health authority queries. This includes the preparation of response to HA queries according to the rapid response process.
  • Maintaining global submission plans and supporting those plans can be executed on time
  • Coordinating and driving global regulatory sub team meetings to ensure high quality meeting discussions & outputs; this includes diligent follow-up with Sub team members to uphold accountabilities and drive decision-making

 What we’ll need from you:

  • Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine).
  • 5-8 years of pharmaceutical industry experience, ideally including experience in regulatory affairs and/or experience in a complementary functional area (e.g., clinical research)
  • Working knowledge of regulatory procedures (US or other)
  • Demonstrates a high-level of self-motivation and professional commitment. Indirect management experience of people or major projects.
  • Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills.
  • Excellent communication skills.
  • Comprehensive understanding of the pharmaceutical industry.
  • Comfortable working in a fast-paced environment where speed is paramount
  • Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions
  • Willingness and ability to effectively work in a highly matrixed team environment
  • Develop understanding of different TAs due to assignment to different projects.
  • Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.
  • Increased exposure to global and multi-functional teams.

Other Qualifications:
• Strong team player with ability to seamlessly collaborate across functional and geographic boundaries to achieve company’s goals

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