Primary Function/Primary Goals/Objectives:
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Combine knowledge of scientific, regulatory and business issues to enable Abbott Nutrition products/business activities to meet required legislation across food and drug.
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Develop and supervise regulatory professionals.
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Have department level influence and be generally recognized as an expert resource both within Abbott and externally.
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Comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.
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Monitor emerging regulatory issues and identify solutions.
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Ensure that data are identified, obtained and effectively presented for the registration of products worldwide.
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Utilize technical regulatory skills to propose strategies on complex issues.
Major Responsibilities:
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Accountable for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents.
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Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
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Identify need for new regulatory policies, processes and SOPs and approve them; evaluate regulatory risks of corporate policies.
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Provide strategic guidance for product development and planning throughout the product lifecycle.
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Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions.
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Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
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Develop regulatory strategies and update based upon regulatory changes,
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Interpret and apply regulatory requirements, oversee activities for regulatory submissions.
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Monitor and influence external environment for impact on company products/business activities (e.g., regulation changes, government practices, trade association activities, etc.), negotiate with regulatory authorities
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Recruit, develop and manage regulatory professionals.
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Ensure regulatory data is maintained in electronic systems.
Supervisory/Management Responsibilities (Influence/Impact/Leadership):
- Manage group or small department, providing direction and guidance to exempt and non-exempt personnel who exercise some latitude and independence in their assignments, including evaluating performance and assisting in career development planning.
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Develop, communicate, and build consensus for operating goals that are in alignment with the division.
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Provide leadership by communicating and providing guidance towards achieving department objectives.
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Interface with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.
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Develop and/or identify new work processes and the improved utilization of resources within groups; investigate and solve problems that impact work processes and personnel across departments.
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Monitor costs of projects and resources within a department.
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Perform work without appreciable direction.
Education:
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Bachelor's degree (or equivalent) is required – preferred area of focus in science (nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, pharmacology, biology, chemistry), math, engineering, or medical fields.
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M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
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Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Background/Skills/Knowledge:
7 - 10 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.
7 - 10 years of experience in a regulated industry (e.g., nutritionals, medical/therapeutic products).
Regulatory knowledge of (as applicable):
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Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc.
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Principles and requirements of promotion, advertising and labeling.
Communication skills and ability to:
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Communicate effectively verbally and in writing.
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Communicate with diverse audiences and personnel.
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Work with and negotiate with people from various disciplines, organizations, and cultures.
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Follow scientific arguments, identify regulatory scientific data needs, solve regulatory issues, and define regulatory strategy.
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Prepare and present written and oral reports to internal and external audiences, including senior management and regulatory agencies.
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Negotiate internally and externally with regulatory agencies.
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Evaluate various technical alternatives and perform risk assessment and analysis.
Other skills:
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Strong attention to detail.
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Create and manage project plans and timelines.
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Manage multiple and competing priorities.
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Think analytically; creatively solve problems; organize and track complex information.
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Plan and conduct effective meetings.
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Proficient computer skills.
Accountability/Scope:
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Execute and manage technical and scientific regulatory activities.
- Function independently as a decision-maker on regulatory issues and assure that deadlines are met.
- Effectively communicate, prepare, and negotiate internally and externally with key stakeholders, various regulatory agencies, trade associations, etc.
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Create immediate to long-range plans to carry out objectives established by top management.
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Develop and calculate a budget for a department or group to meet organizational goals; Forecast future departmental needs including human and material resources and capital expenditures.
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Recommend or modify the structure of organizational units or a centralized functional activity subject to senior management approval.
