Director, Regulatory Affairs – Abbott Nutrition China

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.