Senior Manager Regulatory Affairs

Senior Regulatory Affairs Manager- REMOTE

I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission planning, coordination, and execution across multiple regions, ensuring smooth and successful interactions with health and regulatory authorities.

• Lead preparation and submission, and maintenance of CTAs to regulatory/health authorities
• Monitor regulatory timelines and ensure compliance with all applicable regulations for IND maintenance
• Lead in the preparation, submission, and maintenance of CTAs to regulatory authorities
• Lead the preparation and execution of health authorities meetings and questions (FDA, EMA, PMDA, etc.)
• Keep track of submissions and approval status globally, providing regular updates and reports to leadership

• At least 8 years in regulatory affairs within the life science space
• Bachelor's degree in life sciences or relevant field
• Strong knowledge of regulatory guidelines and clinical trial regulations
• Proven experience with global CTAs submissions and IND maintenance
• Ability to manage multiple priorities and work in a fast-paced, dynamic environment

This role comes with a competitive base salary and benefits.

• Medical insurance
• Pension plan
• Child care support
• Vision insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Student loan assistance

• Not Applicable

• Full-time

• Science

Referrals increase your chances of interviewing at Barrington James by 2x.