Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Project Manager Regulatory Operations

Primary Function/Primary Goals/Objectives: 

Combine knowledge of scientific, regulatory and business issues to enable Abbott Nutrition products to meet required legislation.  Have department/group/site level influence and be generally recognized as an expert resource within the department.  May also share knowledge and expertise with others in support of team activities.   Identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance. Identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Utilize technical regulatory skills to propose strategies on complex issues.

Major Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents. Responsible for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs. Provide regulatory input to product lifecycle planning and in all stages of product development. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions. Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes. Interpret and apply regulatory requirements. Monitor and influence external environment for impact on company products/business activities (e.g., regulation changes, government practices, trade association activities, etc.). Develop and mentor regulatory professionals. Maintain regulatory data in electronic systems. May be involved in various regulatory activities (regulatory submissions; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses and registrations; review and approval of label changes, advertising and promotional items; project management etc.).   

Supervisory/Management Responsibilities (Influence/Impact/Leadership):  

Provide leadership without direct authority (i.e., project leader) and provide direction and guidance to other personnel who exercise significant latitude and independence in their assignments.  May mentor other department members. 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 on significant matters, often requiring the coordination of activity across organizational units. Perform work without appreciable direction.

Background/Skills/Knowledge:

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.

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. 

Educations Requirements:

• Bachelor’s Degree