Remote Associate Director, Global Regulatory – Biologics

Candel Therapeutics; Needham (MA); Remote; USD 154,000 - 215,000; Full time

Job summary

Candel is seeking an Associate Director, Regulatory Affairs to lead global regulatory strategies for oncology ATMP programs across US, EU, UK, Japan and other regions.

You will partner with Clinical, CMC, Quality, Research and Commercial teams, manage regulatory submissions, and navigate ex-US health authorities to enable timely approvals while aligning with risk and compliance frameworks.

Qualifications

• 8+ years of progressive experience in biopharma, with 5+ years in regulatory roles.
• Direct experience supporting multinational late-stage trials and multi-country CTA submissions.
• Experience with ex-US health authorities (EMA, MHRA, PMDA).
• Experience with biologics and ATMP regulatory frameworks.
• Strong writing and cross-functional leadership.

Responsibilities

• Develop global regulatory strategies for programs across US, EU, UK, Japan and other target markets.
• Lead regulatory submissions and interactions with health authorities.
• Coordinate with CROs and regional consultants for regulatory filings.
• Maintain regulatory risk assessments and ensure compliant documentation.
• Collaborate with Clinical, CMC, Quality, Research and Commercial teams.

Skills

Regulatory strategy

Global submissions

Cross-functional collaboration

Leadership

Education

Bachelor’s degree

RAC certification

Tools

eCTD knowledge

Job description

Candel is seeking an Associate Director, Regulatory Affairs to lead global regulatory strategies for oncology ATMP programs across US, EU, UK, Japan and other regions.

You will partner with Clinical, CMC, Quality, Research and Commercial teams, manage regulatory submissions, and navigate ex-US health authorities to enable timely approvals while aligning with risk and compliance frameworks.