Sr. Specialist Regulatory Affairs at Abbott Laboratories

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 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of!

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our location in the South Portland, Maine. This is in the Abbott Infectious Disease Unit. This role is on site and is not hybrid. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

What You’ll Work On

The Sr. Specialist, Regulatory Affairs combines scientific, regulatory, and business knowledge to ensure that products, including capital equipment and software, comply with legislation. This individual is recognized as an expert within the department and influences at the department, group, and site levels. They share their expertise to support team activities, identify necessary data, and ensure effective presentation for global product registration.

Responsibilities:

• Coordinate input from multiple areas or project managers on related projects.

• Develop project specifications, objectives, strategies, timelines, and milestones. Utilize project scheduling software to plan and track projects.

• Identify resource requirements, costs, and time schedules. Develop implementation plans, conduct risk assessments, and create contingency plans for unforeseen events.

• Lead cross-functional teams through project planning to develop detailed schedules and integrated project plans.

• Define business or technical problems and develop alternatives to address major issues. Assist management in selecting action plans that meet long-term business goals.

• Anticipate future problems, resolve current issues, and adjust based on prior results and project leadership experience.

• Ensure projects integrate with existing programs and strategies to achieve long- and short-term business goals.

• Recognize broader implications of actions and proposals on project outcomes, related systems, and business strategy.

• Prepare and present project progress reports to management and teams, identifying problems, resolutions, trends, and impacts on project success. Propose recommendations for management action.

• Analyze data to identify true causes of problems.

• Negotiate project outcomes and deliverables to balance time, money, and deadlines. Maintain project expenses within budget.

• Drive cross-functional teams to meet milestones and deliverables agreed upon with senior leadership.

• Serve as the project contact with third-party vendors when necessary.

• Accountable for total project scope, completion within budget constraints, and scheduled completion dates.

• Ensure successful completion of project tasks under direct or matrix control.

• Level load work to ensure effective use of available resources.

• Solicit cooperation from diverse disciplines and functions in a tactful and persuasive manner.

• Lead others in completing project tasks and manage the decision-making process.

• Manage a cross-functional team, which may include senior-level individual contributors.

• Act as the final decision-maker for conflicts within the agreed-upon project plan.

• Create a work environment that supports team effectiveness and provide feedback on performance.

• Interact with senior management to agree on significant program strategies.

• Interface with other disciplines, customers, internal clients, project staff, and internal/external experts as required.

• Prepare and present written and oral reports and other presentations to internal and external audiences, adjusting style and content to suit the audience.

• Negotiate resources, both labor and financial.

Required Qualifications

• Bachelor’s degree (or equivalent) required, preferably in science, engineering, or medical fields.

• Minimum of 3 years of experience in regulatory affairs preferred; experience in quality assurance, research and development, scientific affairs, operations, or related areas may be considered.

• 3-6 years of experience in regulatory affairs submissions.

• Expertise with EDMS (Documentum-based), publishing, and/or registration management systems, Adobe Acrobat, or similar tools.

• Demonstrated ability to quickly learn new technology.

• Expertise with electronic submission formats like eCTD, ACTD, and NeeS.

• Knowledge of relevant regulations.

• Excellent written and oral communication skills.

Preferred Qualifications:

• M.S. in a technical area or M.B.A. preferred.

• 3-6 years of pharmaceutical publishing experience preferred.

• Ph.D. in a technical area or law is helpful.

• Certification such as RAC from the Regulatory Affairs Professionals Society is a plus.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.