Manager, Regulatory Affairs

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

Our client is seeking an experienced regulatory professional to support global regulatory activities across early- and late-stage development programs through lifecycle management.

The Manager, Regulatory Affairs will partner cross-functionally to support high-quality regulatory submissions and help drive successful interactions with global health authorities.

This role will support regulatory strategy and execution for submissions including INDs, CTAs, NDA components, supplements, and other product-related regulatory activities.

The ideal candidate brings strong knowledge of U.S. and international regulatory requirements, excellent collaboration skills, and the ability to manage multiple priorities in a fast-paced environment.

Key Responsibilities:

Support preparation, review, and submission of regulatory filings including INDs/CTAs, amendments and information requisitions, 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. Represents regulatory for global study-level regulatory activities included but not limited to 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 / Qualifications:

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.