Strategic CMC Regulatory Lead - Associate Director

ABBVIE; Irvine (CA); On-site; USD 142,000 - 269,000; Full time

Job summary

AbbVie in Irvine, CA is seeking an Associate Director Regulatory Affairs, CMC to lead global regulatory strategies for complex biologics and small molecules.

You will prepare CMC submissions (INDs/CTAs), manage change control, and coordinate cross‑functional teams with R&D, manufacturing and QA.

The role requires 8+ years in pharma with leadership, strong communication, and the ability to influence Health Authorities in a dynamic, matrix environment.

Qualifications

• 8 years pharmaceutical experience with at least 3 years in leadership.
• 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing successful global regulatory strategies.
• Experience working with Health Authority and in complex matrix environments.
• Strong oral and written communication skills.

Responsibilities

• Prepares CMC regulatory product strategies and submissions.
• Analyzes information that impacts regulatory decisions and seeks expert advice as needed.
• Reviews and revises regulatory submissions to present data effectively.
• Develops strategies for CMC agency meetings and prepares pre-meeting submissions.
• Manages change control and manufacturing change requests.
• Represents CMC regulatory affairs on cross-functional teams to maximize first-pass approvals during regulatory submissions.
• Keeps abreast of regulatory changes and provides analysis to the organization.
• Develops, implements, and documents RA policies; leads RA initiatives.
• Represents RA CMC on project initiatives to drive efficiencies across the company.
• Trains, develops and mentors team members; may include supervisory responsibilities.

Skills

Strong oral and written communication

Leadership

Education

Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject

Relevant advanced degree preferred

Job description

AbbVie in Irvine, CA is seeking an Associate Director Regulatory Affairs, CMC to lead global regulatory strategies for complex biologics and small molecules.

You will prepare CMC submissions (INDs/CTAs), manage change control, and coordinate cross‑functional teams with R&D, manufacturing and QA.

The role requires 8+ years in pharma with leadership, strong communication, and the ability to influence Health Authorities in a dynamic, matrix environment.