Head of Regulatory Affairs — Global Submissions & Strategy

Noema Pharma AG; Watertown (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Noema Pharma AG in the Boston area is seeking a Director of Regulatory Affairs to provide strategic and operational leadership across development and commercialization programs. You will shape regulatory strategy and lead submissions for INDs, NDAs, MAAs and related supplements while coordinating with cross-functional teams.

This senior role involves direct interaction with FDA and other health authorities, organizing meetings, managing risk assessments, ensuring trial disclosure compliance, and

Qualifications

• Bachelor's degree in life sciences required; advanced degree preferred.
• 10+ years pharmaceutical regulatory experience.
• Experience in multinational development, registration and marketing requirements.
• Familiarity with CTD formats.
• Strong leadership and communication skills; ability to influence decisions.

Responsibilities

• Develop and implement regulatory strategy and prepare regulatory submissions for INDs, NDAs, MAAs, and supplements.
• Interact with FDA and health authorities to facilitate IND/NDA assessments.
• Organize meetings with Health Authority personnel to obtain commitments for rapid development.
• Coordinate regulatory submissions in global clinical studies across programs.
• Review and submit clinical and nonclinical development reports and regulatory documents.
• Provide regulatory oversight and guidance on compliance, study design issues, and timing.

Skills

Strategic leadership

Regulatory affairs

FDA submissions

Project management

Interpersonal communication

Regulatory intelligence

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

eCTD formats

Job description

Noema Pharma AG in the Boston area is seeking a Director of Regulatory Affairs to provide strategic and operational leadership across development and commercialization programs. You will shape regulatory strategy and lead submissions for INDs, NDAs, MAAs and related supplements while coordinating with cross-functional teams.

This senior role involves direct interaction with FDA and other health authorities, organizing meetings, managing risk assessments, ensuring trial disclosure compliance, and