Associate Director, CMC RA — Regulatory Strategy Lead

BioSpace; North Chicago (IL); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Health/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbVie seeks an Associate Director Regulatory Affairs (CMC) to develop regulatory strategies, prepare submissions and manage interactions with agencies. You will lead cross-functional teams across product development, operations and R&D to enable first-pass approvals and ensure compliant CMC documentation.

The role requires a Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field, 8 years pharma experience with leadership, and strong written and oral

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related subject.
• Advanced degree preferred; certification a plus.
• 8 years pharmaceutical experience with at least 3 years of leadership.
• 10 years pharma experience preferred; 5+ years in regulatory affairs or 5+ in Discovery/R&D/Manufacturing.
• Experience with global regulatory strategies and Health Authority interactions.
• Experience in complex matrix environments and strong communication skills.

Responsibilities

• Prepare CMC regulatory product strategies and submissions.
• Analyze information impacting regulatory decisions and seek expert advice.
• Review and revise regulatory submissions for clarity and compliance.
• Lead agency meeting preparation and ongoing regulatory correspondence.
• Manage change control and manufacturing change requests.
• Represent CMC regulatory affairs on cross-functional teams to drive approvals.
• Stay updated on regulatory changes and ensure internal alignment.
• Develop and implement RA CMC policies and procedures.

Skills

Regulatory strategy

Global submissions

Stakeholder management

Leadership

Regulatory affairs

Education

Bachelor's in Pharmacy/ Chemistry/ Biology/ Pharmacology/ Engineering

Advanced degree preferred

Job description

AbbVie seeks an Associate Director Regulatory Affairs (CMC) to develop regulatory strategies, prepare submissions and manage interactions with agencies. You will lead cross-functional teams across product development, operations and R&D to enable first-pass approvals and ensure compliant CMC documentation.

The role requires a Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field, 8 years pharma experience with leadership, and strong written and oral