Associate Director, CMC Regulatory Strategy

BioSpace; North Chicago (IL); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

AbbVie seeks an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies and submissions. You will collaborate with internal and external partners to deliver products, negotiate with agencies, and guide teams on first-pass approvals across INDs/CTAs and variations.

The role emphasizes strategic liaison with agencies (e.g., FDA), content strategy for submissions, and cross-functional collaboration with R&D, Operations, and product teams.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• Advanced degree preferred; certification a plus.
• 8 years pharmaceutical experience with at least 3 years of demonstrated leadership.
• 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing.

Responsibilities

• Prepares CMC regulatory product strategies and manages submissions, renewals, and amendments.
• Interprets information impacting regulatory decisions and seeks expert advice as needed.
• Reviews and revises regulatory submissions to present data and strategy clearly to agencies.
• Leads agency meeting prep and serves as point of contact for regulatory meetings.
• Manages change control and approves manufacturing change requests.

Skills

Regulatory strategy

CMC

Leadership

Global submissions

Regulatory affairs

Education

Bachelor's degree in Pharmacy

Advanced degree preferred

Job description

AbbVie seeks an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies and submissions. You will collaborate with internal and external partners to deliver products, negotiate with agencies, and guide teams on first-pass approvals across INDs/CTAs and variations.

The role emphasizes strategic liaison with agencies (e.g., FDA), content strategy for submissions, and cross-functional collaboration with R&D, Operations, and product teams.