Associate Director of Regulatory Affairs, CMC (Fully Remote)

Unknown; United States; Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

PTO

Remote work

Job summary

Unknown biotechnology organization seeks a senior CMC regulatory expert to support late-stage cell therapy programs. You will author CMC sections for regulatory submissions and lead interactions with FDA, EMA, and ANVISA from a remote US location.

The role requires 7+ years of CMC regulatory experience, with 3–5 years in cell therapy, and strong Module 3/CTD writing skills. Comprehensive benefits and a competitive salary are offered.

Qualifications

• 7+ years CMC regulatory experience, including cell therapy exposure.
• 3–5 years experience in cell therapy programs.
• Strong Module 3/CTD writing experience with FDA/EMA/ANVISA know-how.

Responsibilities

• Authors CMC sections for BLAs, MAAs, IMPDs, and supplements.
• Manages lifecycle activities and health authority interactions.

Skills

CMC regulatory

FDA experience

EMA experience

ANVISA experience

Cell therapy

Job description

• Supports late-stage development and commercial launch for a cell therapy pipeline.
• Provides hands-on CMC regulatory expertise globally.

Key Responsibilities

• Authors CMC sections for BLAs, MAAs, IMPDs, and supplements.
• Manages lifecycle activities and health authority interactions.

Requirements

• 7+ years CMC regulatory experience, including 3–5 years in cell therapy.
• Strong Module 3/CTD writing and FDA/EMA/ANVISA experience.
• Remote US role with competitive salary and comprehensive benefits.
• Medical, dental, vision, 401(k), and PTO included.

The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.