Global Regulatory Affairs Director — Strategy & Submissions

Noema Pharma AG; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and commercializing products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA, and ensure compliance with relevant laws and regulations. Qualified candidates will have a Bachelor's degree in life sciences, over 10 years of regulatory experience, and strong communication and leadership skills. This role is vital for supporting ongoing global clinical studies.

Qualifications

• 10+ years pharmaceutical industry regulatory experience.
• Experience in multi-national development and marketing requirements.
• Familiarity with CTD formats.

Responsibilities

• Develop and implement regulatory strategy and submissions.
• Interact directly with health authorities like the FDA.
• Provide regulatory oversight and guidance to project teams.

Skills

Leadership abilities

Excellent communication skills

Project management skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and commercializing products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA, and ensure compliance with relevant laws and regulations. Qualified candidates will have a Bachelor's degree in life sciences, over 10 years of regulatory experience, and strong communication and leadership skills. This role is vital for supporting ongoing global clinical studies.