Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Primary Job Function:
Leads global regulatory strategies for Heart Failure devices. Directs and guides the management team in the establishment and achievement of regulatory objectives including updating regulatory requirements for products from concept through manufacturing. Provides leadership to the Regulatory Affairs department including allocation and management of department resources to accomplish key objectives. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and act as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy.
Core Job Responsibilities: Strategic planning of worldwide submissions Responsible for compliance with applicable policies and procedures Recruits, coaches and develops regulatory talent Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives Creates an entrepreneurial environment Provides general direction to associate directors, managers, and specialists Keeps organizations vision and values at the forefront of decision-making and action Demonstrates effective change leadership Builds strategic partnership to further develop department and organization objectives Interacts with executive level management, outside regulatory agencies, customers, vendors and/or suppliers Coordinates across functional areas, business units, and/or geographies to achieve company or geographic goals Oversees worldwide Advertising and Promotion (A&P) approvals Directs and controls the budget Updates team on changing regulations
Position Accountability / Scope:
Scope is to provide regulatory direction for product development and support the strategy for approval to global market products to meet business objectives; administer /meet regulatory requirements to achieve compliant status; attract and develop superior regulatory professionals with regulatory competencies. Assure that all deadlines are met and provide effective direction to the regulatory team. Work is performed without appreciable direction; determine technical objectives of assignments; determine and pursue courses of action necessary to obtain desired results. Individual is recognized as a key opinion leader and worldwide divisional resource in regulatory affairs.
Influence/Leadership: Develops, communicates, and builds consensus for operating goals that are in alignment with the business unit and corporation. Provides leadership by communicating and providing guidance towards achieving department, business unit and/or corporate objectives. Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across various business units Provides technical leadership to business units Acts as a mentor to less-experienced staff internal and external to the department/business unit Exercises judgment independently Leads the regulatory department by developing, communicating, and building consensus for goals and programs that support business unit and company objectives
Planning/Organization: Creates mid- to long-range plans to carry out objectives established by top management Develops and calculates a budget to meet organizational goals Forecasts future departmental or group needs including human and material resources Determines and establishes organizational structure and supervisory relationships subject to top management approval
Decision Making/Impact: Assignments are expressed in the form of objectives Work is performed without appreciable direction Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.
Bachelor's degree and 12+ years of related work experience or an equivalent combination of education and work experience in a regulated industry (e.g., medical products, pharma, etc.). Advanced degree preferred.
Minimum Experience / Training Required
Regulatory Knowledge of (as applicable): Regulatory history, guidelines, policies, standards, practices, requirements and precedents Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws, submission/registration types and requirements GxPs (GCPs, GLPs, GMPs) Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial trade requirements, agreements and considerations Domestic and international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory process Lead functional groups in the development of relevant data to complete a regulatory submission Ability to monitor costs of projects and of human and material resources within a department or unit Monitors progress of departments or units toward divisional and company goals; Monitors all costs associated with assigned organizational unit; monitors company-wide indicators such as market share and profitability; monitors industry trends and external environment in areas relevant to the assigned organizational unit. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Develops and/or identifies new work processes that will have broad applicability throughout the company; contributes ideas for improving work processes and achieving organizational goals; Investigates and solves problems that impact work processes and personnel in multiple units or departments; Develops and communicates a vision for a major segment of the organization.
Associated topics: analyst, care, chief marketing officer, demand, fundraise, major gift, policy, policies, principle gift, regulatory