Senior RA CMC Leader: Regulatory Strategy & Submissions

BioSpace; Irvine (CA); On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Comprehensive health benefits

401(k) retirement plan

Long-term incentive programs

Job summary

AbbVie in the Irvine area seeks an Associate Director Regulatory Affairs, CMC to lead regulatory strategies for product submissions, drive INDs/CTAs, and coordinate with RA, R&D and Operations to ensure first-pass approvals.

The role emphasizes global submissions, agency interactions (FDA), and mentorship of staff, with a strong emphasis on communication and regulatory science in a complex matrix environment.

Qualifications

• Bachelor’s degree in a science/engineering field is required.
• 8 years of pharmaceutical experience with 3+ years in leadership.
• Experience with global regulatory strategies and Health Authority interactions.

Responsibilities

• Prepare CMC regulatory product strategies and submissions.
• Lead regulatory submissions, renewals, and agency communications.
• Develop content strategy for INDs/CTAs and variations.
• Mentor RA team and collaborate with cross‑functional groups.

Skills

Communication skills

Education

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

Advanced degree preferred

Regulatory affairs certification a plus

Job description

AbbVie in the Irvine area seeks an Associate Director Regulatory Affairs, CMC to lead regulatory strategies for product submissions, drive INDs/CTAs, and coordinate with RA, R&D and Operations to ensure first-pass approvals.

The role emphasizes global submissions, agency interactions (FDA), and mentorship of staff, with a strong emphasis on communication and regulatory science in a complex matrix environment.