Regulatory Affairs Associate
Needham, MA
Full Time
Entry Level
**This is a hybrid position based in Needham. Onsite presence of 1–2 days/week is expected. All candidates must live within commuting distance to office.
Work Authorization:
Applicants must be currently authorized to work in the United States on a full-time basis. We are not able to sponsor or take over sponsorship of employment visas at this time.
Why Work With Us?
At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.
Our Science: Advancing Cancer Immunotherapies
Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com
Who You Are:
Are you someone who loves solving problems, thrives on learning new things, and wants to be part of something meaningful? As a Regulatory Affairs Associate, your curiosity, attention to detail, and drive to do things right will directly support the development of life-changing cancer therapies.In this role, you’ll contribute to Candel’s regulatory strategy and day-to-day operations by assisting in the planning, development, coordination, submission, and archival of controlled documents to regulatory authorities—including, but not limited to, the U.S. Food and Drug Administration (FDA). You won’t just be tracking submissions—you’ll be learning the why behind the work, growing your regulatory expertise, and becoming a valued partner on a mission-driven team.
Whether you’re early in your career or transitioning from a clinical or data-focused role, this is your opportunity to gain hands-on experience, make a tangible impact, and help bring new hope to patients.
What You’ll Do:
Submission Process
- In consultation with Regulatory staff and cross-functional team members, support the planning, authoring, review, and finalization of US regulatory submissions.
- Coordinate with consultants to contribute to submission preparation and to help ensure accurate, complete, compliant and timely electronic regulatory submissions.
- Manage the spreadsheet with all weekly/monthly regulatory submissions and communicating the information with the publishing vendor.
- Collaborate with the publishing vendor for e-submission files and submission receipts.
- Maintain templates and style guides for regulatory submissions.
Archiving
- Maintain the IQVIA RIM system and ensuring that all regulatory records are up to date.
- Archive regulatory submissions and other controlled documents in accordance with Regulatory procedures and processes.
- Contribute to due diligence and other archive-review processes in support of company objectives and regulatory submissions.
Regulatory Intelligence
- Conduct research into precedence of relevant prior applications and provide strategic and tactical recommendations based on the information.
- Stay abreast of regulatory procedures and changes in regulatory climate, particularly as they are reflected in US agency regulations and guidances.
What You Bring:
- Bachelor’s degree in life science or related field.
- Certificate or Master’s degree in Regulatory Affairs a plus.
- One to two years of experience within the life science industry (e.g., positions such as Clinical Research Associate or Data Management if regulatory roles not previously held).
- Basic knowledge/understanding of regulatory requirements for biological products, including understanding of how INDs/BLAs work.
- Familiarity with the application process for US clinical and commercial products.
- Proficiency in time management and detail oriented.
- Proficiency with MS Office and Adobe applications.
- Excellent verbal, written and interpersonal skills.
- Research skills and experience using databases to conduct complex inquiries.
- Excellent organization skills and ability to work on multiple projects with tight timelines.
- Able to adapt to program/timeline changes as needed.
- Self-motivated and able to work independently with oversight from Associate Director, Regulatory Affairs.
Why You’ll Succeed at This Role:
- You’re not afraid to ask, “Why?”—and you care about the answer.
- You want to understand the patient impact behind the process.
- You have a respect for and a desire to work within a diverse employee culture.
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