Job details

Director, Regulatory Affairs CMC

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on patients with genetically defined diseases. They seek a Director of Regulatory Affairs CMC to lead the development and implementation of regulatory strategies.

Skills

Strategic thinking
Tactical skills
Regulatory expertise
Project management
Communication skills

Responsibilities

Lead the development and execution of RA CMC submission strategies.
Assess and communicate RA CMC requirements and risks.
Prepare and submit CMC content for various regulatory submissions.
Liaise with global health authorities.
Maintain knowledge of FDA/ICH CMC regulatory requirements.
Manage RA CMC vendors and consultants.

Education

Bachelor's degree in life sciences
Advanced degree preferred

Benefits

Competitive salary
Health insurance
Retirement plan
Flexible working conditions
Professional development opportunities

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By Fulcrum Therapeutics

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's two lead programs in clinical development are losma...

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FUNDING

Growth

DEPARTMENTS

Consulting

SENIORITY LEVEL REQUIREMENT

Senior

INDUSTRY

Health Care

TEAM SIZE