Manager, Regulatory Affairs

The Manager, Regulatory Affairs supports global regulatory activities for early- and late-stage development programs, ensuring high-quality submissions and successful interactions with health authorities. The role requires collaboration across functions and expertise in regulatory requirements.

Location: United States

Salary: $116,000 - $160,000

Responsibilities

• Support preparation, review, and submission of regulatory filings including INDs/CTAs, amendments, Orphan drug applications, Annual Reports, and Investigator’s Brochures.
• Assist in coordination and preparation of global health authority meeting documents.
• Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards.
• Represent regulatory for global study-level regulatory activities including study start-up, study maintenance, and end of trial activities.
• Collaborate with external partners and vendors on regulatory activities and submission support.
• Support regulatory operations and continuous improvement initiatives, including work instruction and SOP development and maintenance.

Requirements

• Bachelor’s degree, preferably in a scientific discipline.
• 6+ years of pharmaceutical industry experience, including 4+ years in Regulatory Affairs.
• Strong knowledge of U.S. and international regulatory requirements for drug development.
• Excellent verbal and written communication, organizational, and cross-functional collaboration skills.
• Strong experience in a self-motivated, fast-paced environment.
• Experience supporting initial INDs/CTAs, and initial marketing application activities is highly desirable.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.