Abbott Regulatory Affairs Program Manager in Alameda, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Exciting new opportunity to join Abbott's fastest growing division, Diabetes Care, home of the FreeStyle Libre continuous glucose monitor (CGM), the world's leading CGM.

MAIN PURPOSE OF ROLE

As the Regulatory Affairs Program Manager, you will...

  • Manage execution of projects in accordance with organization's project management methodology.

  • Develop, prioritize and submit regulatory project plans, budgets and methodologies across a range of key projects and across various countries.

  • Define project resources, for pre and post implementation activities.

  • Take ownership of the successful implementation of a set of projects that collectively can comprise a program.

  • Manage the work of Senior Regulatory Affairs Specialists.

MAIN RESPONSIBILITIES

• Lead regulatory projects with Senior Regulatory Affairs Specialists.

• Assist in the development of multi- country regulatory strategy and update strategy based upon regulatory changes.

• Monitor progress and performance against the project plan.

• Identify and resolve operational problems and minimize delays.

• Evaluate and authorize changes that significantly impact the scope, budget, or timeline of a project.

• Identify emerging issues and propose strategies.

• Select and manage ongoing relationships with external contractors so that the organization receives satisfactory standards of service.

• Lead, direct, evaluate, and develop a team of project managers to ensure that projects are completed on-time, within budget and according to project specifications.

QUALIFICATIONS

Minimum Education

Bachelor's degree (preferably in engineering, science or a closely related discipline is desired) or equivalent technical experience and demonstrated competence; an advanced degree (such as a Master's or MBA) is preferred; post-graduate education may contribute toward the desired years of experience.

Minimum Experience / Training Required

Typically requires 8+ years of experience in a complex, technical program / project management role to develop the competence required to meet the skills and responsibilities of the position. Regulatory affairs experience is strongly preferred.

Candidates / incumbents should possess the following:

  • skilled in effective leadership, planning, analysis and communication;

  • strong decision-making and problem-solving skills; demonstrated good judgment;

  • ability to be creative in achieving objectives while assuring compliance to internal and external requirements;

  • working knowledge of new product development methodologies;

  • ability to utilize commonly accepted project management tools to assist in the development of and adherence to a schedule;

  • ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors;

  • ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior;

  • ability to work independently and in groups; ability to work cross-functionally;

  • ability and aptitude to use various types of databases and other computer software;

  • ability to prioritize.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com