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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 鈥� immunology, oncology, neuroscience, and eye care 鈥� and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at听. Follow @abbvie on听,听,听,听,听听补苍诲听.

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.

Additional Responsibilities Include:

• 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.
• Provides internal guidance and acts as a subject matter expert in various regulatory and technical aspects of small molecule CMC development such as peptides and sterile injectables.
• 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

This role is a hybrid onsite opportunity based in AbbVie's Lake County, IL office.听

• Required Education: Bachelor鈥檚 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

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or听local law:听鈥�

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

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

• This job is eligible to participate in our short-term incentive听programs.听鈥�

• This job is eligible to participate in our long-term incentive听programs鈥�

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

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

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