Senior Director, Global Regulatory Lead

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 – from early- to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Please visit www.candeltx.com for additional information.

The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies, and programs pertaining to development and marketing of biological products. This role includes the lead regulatory responsibility for support of global registration and life cycle support and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.) coordinating departmental and cross functional support.

Responsibilities:

  • Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations. Single point of contact and accountability for regulatory and leads the regulatory sub teams as well as represents regulatory on global development teams.
  • Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for assigned projects.
  • Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
  • Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
  • Provides guidance to all appropriate departments in Candel to assure compliance with applicable regulations.
  • Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel.
  • Makes recommendations for regulatory department operating procedures.
  • May be responsible for creating and reviewing SOPs.
  • May supervise Regulatory Affairs Associates.
  • Actively trains/mentors’ junior staff; provides broader guidance on regulatory interpretation to Candel staff.
  • Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and directions for major functional areas. Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.

Requirements:

  • BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
  • Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical industry in other areas.  The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as US, EU, Japan, and Canada) to ensure appropriate leadership and mentoring for regulatory staff within Candel.
  • Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).
  • Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
  • Ability to present complex issues in oral and written form
  • Experienced in responding to inquiries from HAs.

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