Director Regulatory Affairs – Abbott Nutrition China

**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/A In 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