Director, RA CMC

• Compensation: USD 160,500 - USD 305,000 - 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

Job Description

The Director I 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 regulatory submissions including INDs/CTAs, amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life‑cycle management teams to negotiate, influence and provide strategic advice to peers and management in RA, R&D and Operations. Serves as a liaison with regulatory agencies (e.g., FDA) regarding CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.

Responsibilities

• Prepare CMC regulatory product strategies and manage regulatory submissions – new IND/CTA applications, amendments, marketing authorizations, renewals, annual reports, supplements and variations.
• Advise internal personnel on regulatory strategies and provide strategic regulatory advice to RA, R&D and Operations.
• Review and revise regulatory submission documentation to effectively present data and strategy to regulatory agencies.
• Design strategies for CMC‑related agency interactions, preparing agency meeting requests and information packages; serve as the point of contact for agency meetings and lead CMC discussions for projects.
• Manage products and change control in compliance with regulations, guidances and company policies; analyze and approve manufacturing change records.
• Represent RA CMC on product development teams and negotiate with team members to maximize chances for first‑pass approval of regulatory submissions.
• Stay abreast of regulatory procedures, analyze legislation, regulation and guidance, and lead creation of white papers and policies.
• Design initiatives to drive business efficiencies across the organization and ensure enterprise culture initiatives are implemented across RA CMC.
• Train, develop and mentor individuals; evaluate performance and assist in career development planning for assigned staff.

Qualifications

• Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• Preferred Education: Relevant advanced degree preferred. Certification a plus.
• Required Experience: 10 years biopharmaceutical experience with 3+ years of demonstrated enterprise leadership; 5+ years in RA or relevant exposure to RA activities.
• Preferred Experience: 10+ years biopharmaceutical RA, R&D or Operations experience, including 7+ years in regulatory affairs; experience developing and implementing successful global regulatory strategies.
• Interfacing ability with government regulatory agencies.
• Success leading in a complex and matrix environment.
• Strong understanding of the business/enterprise.
• Strong oral and written communication skills.

Additional Information

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick days), medical/dental/vision insurance and a 401(k) to eligible employees.

This position is eligible to participate in our long‑term incentive programs.

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.