Associate Director, Regulatory Affairs (Fully Remote)

N A; United States; Remote; USD 130,000 - 180,000; Full time

Job summary

N A in the United States is seeking a strategic regulatory affairs leader to guide regulatory strategy for oncology biologics and cell/gene therapies in a fully remote, globally exposed role. You will develop US and global development pathways, prepare submissions, and lead health authority interactions while coordinating with cross-functional teams.

The ideal candidate has a life sciences degree and 5+ years in regulatory affairs, with late-stage oncology experience and knowledge of biologics;

Qualifications

• Bachelor's degree in life sciences with 5+ years of regulatory affairs experience.
• Late-stage oncology drug development experience and knowledge of biologics or advanced therapies.
• Strong communication, organizational, and strategic negotiation skills.

Responsibilities

• Develop and execute U.S. and global regulatory strategies for assigned programs.
• Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
• Lead health authority interactions and cross-functional regulatory planning.

Skills

Strong communication

Organizational skills

Strategic negotiation

Education

Bachelor's degree in life sciences

Job description

• This fully remote role leads U.S. and global regulatory strategy for innovative oncology biologic programs.
• You will shape development pathways and submission plans for cell and gene therapies.

Key Accountabilities:

• Develop and execute U.S. and global regulatory strategies for assigned programs.
• Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
• Lead health authority interactions and cross-functional regulatory planning.

Candidate Requirements:

• Bachelor's degree in life sciences with 5+ years of regulatory affairs experience (or equivalent).
• Late-stage oncology drug development experience and knowledge of biologics or advanced therapies.
• Strong communication, organizational, and strategic negotiation skills.

Why This Role:

• Opportunity to work fully remotely with global health authority exposure.
• Collaborate with cross-functional leaders on innovative oncology therapies.

A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.