Associate Director, Regulatory Affairs

Candel is seeking an Associate Director, Regulatory Affairs to develop and execute global regulatory strategies for assigned programs, ensuring alignment across US, EU, UK, Japan, and other regions. The successful candidate will bring substantial experience navigating the global regulatory landscape for biologics and demonstrated expertise in late-stage clinical development and ex-US health authority interactions.

Requirements

• Bachelor's degree
• RAC certification is a plus
• 8+ years of progressive experience within the biopharmaceutical industry
• Minimum 5 years focused in regulatory and a substantial portion in global or international regulatory roles preferred
• Direct experience supporting multinational late-stage (Phase II/III or pivotal) clinical trials
• Experience working with ex-US health authorities, including EMA (centralized procedure, Scientific Advice, CAT/CHMP interactions), MHRA, Health Canada, PMDA, TGA, or other major regulatory agencies
• Experience with biologics development, including familiarity with the regulatory framework for biological products
• Experience working with CROs and regulatory consultants to manage multi-country regulatory filings and health authority interactions
• Track record of authoring or leading the preparation of major regulatory submissions (INDs/CTAs, marketing applications, or significant supplements/variations)

Benefits

• Paid time off
• 401k matching
• Health insurance
• Dental insurance
• Vision insurance