About this role
JOB DESCRIPTION: Primary Function/Primary Goals/Objectives:
• Combine knowledge of scientific, regulatory and business issues to enable Abbott Nutrition products/business activities to meet required legislation across food and drug. • Develop and supervise regulatory professionals. • Have department level influence and be generally recognized as an expert resource both within Abbott and externally. • Comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. • Monitor emerging regulatory issues and identify solutions. • Ensure that data are identified, obtained and effectively presented for the registration of products worldwide. • Utilize technical regulatory skills to propose strategies on complex issues.
Major Responsibilities:
• Accountable for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents. • Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs. • Identify need for new regulatory policies, processes and SOPs and approve them; evaluate regulatory risks of corporate policies. • Provide strategic guidance for product development and planning throughout the product lifecycle. • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions. • Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. • Develop regulatory strategies and update based upon regulatory changes, • Interpret and apply regulatory requirements, oversee activities for regulatory submissions. • 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 • Recruit, develop and manage regulatory professionals. • 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. • Develop, communicate, and build consensus for operating goals that are in alignment with the division. • Provide leadership by communicating and providing guidance towards achieving department objectives. • Interface with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units. • 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. • Monitor costs of projects and resources within a department. • Perform work without appreciable direction.
Education:
• 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. • M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. • 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):
• Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc. • Principles and requirements of promotion, advertising and labeling.
Communication skills and ability to:
• Communicate effectively verbally and in writing. • Communicate with diverse audiences and personnel. • Work with and negotiate with people from various disciplines, organizations, and cultures. • Follow scientific arguments, identify regulatory scientific data needs, solve regulatory issues, and define regulatory strategy. • Prepare and present written and oral reports to internal and external audiences, including senior management and regulatory agencies. • Negotiate internally and externally with regulatory agencies. • Evaluate various technical alternatives and perform risk assessment and analysis.
Other skills:
• Strong attention to detail. • Create and manage project plans and timelines. • Manage multiple and competing priorities. • Think analytically; creatively solve problems; organize and track complex information. • Plan and conduct effective meetings. • Proficient computer skills.
Accountability/Scope:
• 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. • Create immediate to long-range plans to carry out objectives established by top management. • 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. • Recommend or modify the structure of organizational units or a centralized functional activity subject to senior management approval. The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: LOCATION: China > Beijing : Canway Building ADDITIONAL LOCATIONS: China > Shanghai : 388 W. Nanjing Road, Ciros Plaza WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable