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. Independently implements and leads Area regulatory strategies and priorities in conjunction with Area regulatory management and collaborates with Global Regulatory Affairs colleagues as appropriate. Identifies and obtains data needed and ensures they are effectively presented for submissions to Health Authorities. Manages Area regulatory submission and approval process. Serve as area point of contact with Health Authorities for routine communications in support of filings. Ensures application of established policies and best practice regulatory standards within Area regulatory for all filings, maintenance of existing product registrations and Health Authority interactions. Assesses Research and Development programs against Area specific regulatory requirements. Responsible for influencing internal customers on Area regulatory issues including commercial, public affairs, clinical development, legal, and others who contribute to regulated communication or communications that could be regulated. Represents Area regulatory on subteams as appropriate. Advises on Area-specific requirements and provides strategic input. Serves as Health Authority point of contact and interface for meetings, teleconferences, etc. Coordinates preparation of Health Authority meeting briefing packages. Begins developing effective relationships with Health Authorities. Manages and leads the preparation and review of regulatory submissions consistent with Area regulatory requirements and guidelines and assures complete and timely responses to Health Authorities during application review. Assures the established policies and standard interpretation of regulations are communicated and followed for assigned projects. Provides regulatory direction regarding marketed products and products in development to support the development of compliant and competitive promotional programs. Responsible for creating and implementing a strategic approach to regulatory compliance for company communication strategies for drug and biological products. Qualifications Bachelor’s or advanced degree in pharmacy, biology, chemistry, pharmacology or related life sciences is required. At least 5 years experience required in Regulatory, R&D, or related area with minimum of 3 years experience preferred in pharmaceutical regulatory activities. Experience interfacing with government regulatory agencies and proven skill at implementing successful global regulatory strategies. Experience working in a complex and matrix environment is required. *Position flexible based on experience Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No 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.