Associate Director, RA CMC

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

• Compensation: USD 141,500 - USD 268,500 - yearly

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

Job Description

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters.

Responsibilities:

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.
• Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization
• Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC.
• Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
• Trains, develops and mentors individuals; may include formal supervisory responsibilities

Qualifications

• Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• Preferred Education: Relevant advanced degree preferred. Certification a plus.
• Required Experience: 8 years pharmaceutical with at least 3 years of demonstrated leadership
• Preferred Experience: 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.
• Experience working in a complex and matrix environment.
• Strong oral and written communication skills.
• Note: Higher education may compensate for years of experience

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the timeof this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.