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.