Associate Director of Regulatory Affairs - Nutrition - Abbott Park, IL/Columbus, OH (OUS Ireland int

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.

Associate Director of Regulatory Affairs

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® - to help get the nutrients they need to live their healthiest life.

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:

• Training and career development , with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1

• Vacation - 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays

• 401(k) retirement savings with a generous company match of 5%

• 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 stability of a company with a record of strong financial performance and history of being actively involved in local communities

The Opportunity

Our location in Lake County, IL currently has an opportunity for an Associate Director Manager of Regulatory Affairs in the Nutrition Division.

What You'll Work On

Primary Function/Primary Goals/Objectives :

• Combine knowledge of scientific, regulatory, and business issues to enable Abbott Nutrition products/business activities to meet required legislation.

• Develop and supervise regulatory professionals.

• Have department level influence and be generally recognized as an expert resource both within Abbott and externally.

• May 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.

• Conduct regulatory due diligence for potential and new acquisitions and advise management.

• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.

• Develop global regulatory strategies and update 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.).

• Recruit, develop and manage regulatory professionals.

• Ensure regulatory data is maintained in electronic systems.

• Depending on specific role, the Associate Director Regulatory Affairs may be involved in various regulatory activities (oversee activities for regulatory submissions; negotiate with regulatory authorities; oversee processes involved with maintaining annual licenses, registrations, ensure external communications meet regulations; lead crisis management program development and implementation; oversee and manage systems related to product safety issues and product recalls, project management, etc.).

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

• May 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.

Accountability/Scope:

• Execute and manage technical and 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.

Required Qualifications

• Bachelor's degree (or equivalent) is required - preferred area of focus in science (biology, chemistry, nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, pharmacology), 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.)

• 5-7 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.

• 5-7 years of experience in a regulated industry (e.g., nutritionals, medical products).

• Note: Higher education may compensate for years of experience or vice versa.

Preferred Qualifications

• Regulatory knowledge of (as applicable):

• Regulatory requirements (guidelines, policies, standards, practices, 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.

MISC:

• This role can be located at Abbott Park, Columbus OH or Global .

Apply Now (~~~)

• 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: ~~~ (~~~)

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 ~~~ , on Facebook at ~~~/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $125,300.00 - $250,700.00. In specific locations, the pay range may vary from the range posted.

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 ~~~ or email ~~~