Director, Global Regulatory Lead – GI & Inflammation

BioSpace; Boston (MA); Hybrid; USD 174,500 - 274,230; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company match

Tuition reimbursement program

Paid vacation and sick leave

Job summary

A leading biotechnology company is seeking a Director, Global Regulatory Lead, GI & Inflammation. The role involves defining global regulatory strategies, leading teams, and ensuring compliance with FDA regulations. Candidates should have over 8 years of pharmaceutical experience, with a strong background in regulatory affairs. This position is classified as hybrid, offering an attractive salary range between $174,500 and $274,230.

Qualifications

• 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience.
• Solid working knowledge of drug development processes and regulatory requirements.
• Ability to interpret complex scientific issues related to regulatory strategy.

Responsibilities

• Define global strategies for regulatory success across multiple projects.
• Accountable for all US FDA submissions and approvals.
• Lead the Global Regulatory Teams and ensure compliance with regulations.

Skills

Regulatory strategy

Project management

Complex problem-solving

Communication skills

Leadership

Education

Bachelor’s Degree in scientific discipline

Advanced degree (PharmD/PhD/MD)

Job description

A leading biotechnology company is seeking a Director, Global Regulatory Lead, GI & Inflammation. The role involves defining global regulatory strategies, leading teams, and ensuring compliance with FDA regulations. Candidates should have over 8 years of pharmaceutical experience, with a strong background in regulatory affairs. This position is classified as hybrid, offering an attractive salary range between $174,500 and $274,230.