Regulatory Operations Manager, Candel Therapeutics, Inc., Needham, MA (Remote)

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:

The Discovery group is seeking a highly motivated, collaborative Research Associate to join a team focused on supporting Candel Therapeutics’ next-generation viral immunotherapy platform, enLIGHTEN. This Research Associate will contribute to the enLIGHTENTM Discovery Platform with hands-on experimental work in the laboratory, including tissue culture, flow cytometry, and cell-based assays.

 What we’ll need from you:

Primary Responsibilities:

  • Responsible for managing Regulatory Affairs compliance for designated domestic and international projects.

    Specific duties and responsibilities include:

    • Assist in the development and maintenance of departmental processes, policies, SOPs and budget forecasts
    • Develop and oversee electronic-submission workplans for the timely development of clinical and commercial submissions
    • Manage technical aspects of regulatory submissions to ensure they comply with standards established by external agencies’ regulations, guidances and special requests
    • Develop and execute audit strategies on a regular basis to advance Regulatory’s business needs, and on a special-case basis in response to internal or external inquiries
    • Develop training materials on Regulatory tools and processes and lead training sessions for staff and external partners
    • Review new US and ex-US regulations, standards, policies, and guidances and apprise staff of changes that affect Regulatory and other internal practices
    • Manage software-implementation and -validation projects for Regulatory Operations
    • Manage the process of obtaining copyright clearance for publications included in regulatory filings, and track associated budget
    • Contribute to the writing and issuance of outward-facing vendor documents, such as RFPs, RFIs, contracts and budget reports

    Position will supervise the work of up to three (3) employees in the positions of Regulatory Operations Associate/Sr. Regulatory Operations Associate.

Qualifications/Requirements:

  • Bachelor’s degree in Regulatory Affairs, Pharmacy, life science, or a closely related field and five (5) years of experience working in pharmaceutical regulatory affairs. Alternatively, will accept a Master’s degree in Regulatory Affairs, Pharmacy, life science, or a closely related field and three (3) years of experience working in pharmaceutical regulatory affairs.

    Experience, which may have been gained concurrently with the primary experience requirement above must include at least three (3) years of:

    • Responsibility for the development, publishing, archiving and preservation of product submissions, particularly as it pertains to product submissions and use of software tools and services
    • Working on clinical and commercial applications to the FDA and at least one ex-US regulatory agency
    • Using Adobe Acrobat and Acrobat plug-ins, MS Project (or other project-management software) and SaS or online databases as they apply to regulatory submissions
    • Conducting historical research across product applications, and external research across US and ex-US regulations and guidances
    • Applying the US CFR as it applies to life science departments of regulatory affairs, and experience with Health Canada and/or EMA regulations.

    Note: this is a telecommuting position working from home. May reside anywhere in the United States. Up to 25% of work in office at Candel Therapeutics offices in Needham, MA required.

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