About AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) Combination Products and Medical Devices Human Factor works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and managers content strategy for regulatory submissions, including new marketing applications, supplements and variations. Builds and maintains relationships within the regulatory affairs functional areas, Operations and Research and Development (R&D) groups. Manages products and change controls in compliance with regulations and company policies and procedures. 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 liaison and strategic partner with FDA. Manages assigned projects within assigned resources. May supervise others. Prepares CMC regulatory product strategies. Seeks expert advice and technical support as required for strategies and submissions Manages the preparation of CMC submissions. Prepares and manages regulatory applications, including new applications and amendments, renewals annual reports, supplements and variations Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests. Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of briefing documents Regularly informs regulatory management of important timely issues Trains, develops and mentors individuals; may include formal supervisory responsibilities Develops and implements policies and procedures within the regulatory affairs department Analyzes legislation, regulation and guidance, provides analysis to the organization Support combination products and medical devices including design control and change management activities. Provides regulatory guidance and support for risk management and human factors engineering topics for drug, biologic, device and combination products Qualifications Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology or related subject Preferred Education: Relevant advanced degree preferred Required Experience: 8 years pharmaceutical or industry related experience. Proven 3+ years in a leadership role with strong management skills Experience working in a complex and matrix environment. Strong communication skills, both oral and written Preferred Experience: 5 years in regulatory affairs. 10 years pharmaceutical experience (medical device/combination product). 5 years in Discovery, R&D, or Manufacturing Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority Note: Higher education may compensate for years of experience *Position flexible based on experience Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.