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