CMC Regulatory Affairs Lead – Associate Director

SmartRecruiters, Inc.; Irvine (CA); On-site; USD 142,000 - 269,000; Full time

Benefits offered by this job

Long-term incentive programs

Medical/dental/vision insurance

Paid time off

Job summary

AbbVie in Irvine, CA is seeking an Associate Director Regulatory Affairs, CMC to develop and execute regulatory strategies for CMC submissions (INDs/CTAs, amendments) and to collaborate with R&D and Operations. You will lead cross-functional teams, prepare agency submissions, manage change controls, and communicate with regulatory authorities to support first-pass approvals.

Ideal candidate has 8+ years pharma experience with leadership in regulatory affairs and a strong track record in global

Qualifications

• Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• Preferred advanced degree; Certification a plus.
• Required experience: 8 years in pharmaceutical industry with at least 3 years of leadership.
• Preferred experience: 10 years pharma including 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing global regulatory strategies and working with Health Authorities.
• Experience in a complex, matrix environment.
• Strong oral and written communication skills.

Responsibilities

• Prepares CMC regulatory product strategies and submissions.
• Analyzes information impacting regulatory decisions and seeks expert input.
• Reviews and revises regulatory submissions for data and strategy.
• Develops strategies for CMC agency meetings and pre-meeting submissions.
• Manages change control and manufacturing change approvals.
• Represent CMC regulatory affairs on cross-functional teams and negotiate with teams.
• Stays abreast of regulatory procedures and changes.
• Develops, implements, and documents RA CMC policies and procedures.
• Trains, develops and mentors individuals; may supervise.

Skills

Regulatory strategy

Health Authority liaison

Regulatory submissions

Cross-functional leadership

Communication skills

Education

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

Advanced degree preferred

Certification a plus

Job description

AbbVie in Irvine, CA is seeking an Associate Director Regulatory Affairs, CMC to develop and execute regulatory strategies for CMC submissions (INDs/CTAs, amendments) and to collaborate with R&D and Operations. You will lead cross-functional teams, prepare agency submissions, manage change controls, and communicate with regulatory authorities to support first-pass approvals.

Ideal candidate has 8+ years pharma experience with leadership in regulatory affairs and a strong track record in global