Global Regulatory Affairs Manager: Submissions & Strategy

The Steely Group; Apex (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

The Steely Group seeks an experienced Regulatory Affairs Manager to drive global regulatory activities across development programs through lifecycle management. Partnering cross-functionally, you will support high-quality regulatory submissions and interactions with global health authorities.

The role covers strategy and execution for INDs, CTAs, NDA components, supplements, and other regulatory submissions, with a strong emphasis on U.S.

Qualifications

• Bachelor's degree 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.

Responsibilities

• Prepare, review, and submit regulatory filings including INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports, and Investigator's Brochures.
• Coordinate and prepare 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 activities including study start-up, 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.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in scientific discipline

Job description

The Steely Group seeks an experienced Regulatory Affairs Manager to drive global regulatory activities across development programs through lifecycle management. Partnering cross-functionally, you will support high-quality regulatory submissions and interactions with global health authorities.

The role covers strategy and execution for INDs, CTAs, NDA components, supplements, and other regulatory submissions, with a strong emphasis on U.S.