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 109,000 colleagues serve people in more than 160 countries.

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, 103,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. 

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. 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.  

Abbott Molecular has an opening in its Des Plaines, IL site for the Manager Regulatory Affairs.

As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.

WHAT YOU’LL DO:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Core job responsibilities for this function may include:

Strategic Planning:

· Develop new regulatory policies, processes and SOPs and train key personnel on them

· Evaluate regulatory risks of division policies, processes, procedures

· Provide regulatory input to product lifecycle planning

· Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management

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

· Utilize technical regulatory skills to propose strategies on complex issues

· Determine submission and approval requirements

· Identify emerging issues

· Monitor trade association positions for impact on company products

· Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

· Recruit, develop and mentor regulatory professionals

· Assess the acceptability of quality, preclinical and clinical documentation for submission filing

· Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions

· Compile, prepare, review and submit regulatory submission to authorities

· Monitor impact of changing regulations on submission strategies and update internal stakeholders

· Monitor applications under regulatory review

· Communicate application progress to internal stakeholders

· Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities

· Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies

· Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval

· Provide strategic input and technical guidance on regulatory requirements to development teams

· Manage and execute preapproval compliance activities

Influence/Leadership:

· Develops, communicates, and builds consensus for operating goals that are in alignment with the division.

· Provides leadership by communicating and providing guidance towards achieving department objectives.

· Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.

· May lead a cross-functional or cross-divisional project team.

· Provides technical leadership to business units.

· Acts as a mentor to less-experienced staff.

· Exercises judgment independently.

Planning/Organization:

· Creates immediate to long-range plans to carry out objectives established by top management.

· Forecasts project related needs including human and material resources and capital expenditures.

Decision Making/Impact:

· Assignments are expressed in the form of objectives

· Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.

· Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

EDUCATION AND EXPERIENCE, YOU’LL BRING  

Required

• Bachelor's degree in science (biology, chemistry, microbiology, immunology,

medical technology, pharmacy, pharmacology), math, engineering, or medical fields is required..

• 4-5 years’ experience in a regulated industry (e.g., diagnostics, medical products, nutritionals).

2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

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

Preferred:

• Advanced degree in a technical area or law is helpful. Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus

Experience:

Regulatory Knowledge of (as applicable):

· Principles and requirements of applicable product laws

· Submission/registration types and requirements

· GxPs (GCPs, GLPs, GMPs)

· Domestic and international regulatory guidelines, policies and regulations

· Ethical guidelines of the regulatory profession, clinical research and regulatory process

Communication Skills or Ability to:

· Communicate effectively verbally and in writing

· Communicate with diverse audiences and personnel

· Write and edit technical documents

· Work with cross-functional teams from various disciplines and cultures

· Negotiate internally and externally with regulatory agencies

Cognitive Skills or Ability to:

· Pay strong attention to detail

· Manage projects

· Create project plans and timelines

· Juggle multiple and competing priorities

· Think analytically with good problem-solving skills

· Organize and track complex information

· Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

· Has broad knowledge of various technical alternatives and their potential impact on the business

· Exercise good and ethical judgment within policy and regulations

· Use in-depth knowledge of business functions and cross group dependencies/ relationships

· Define regulatory strategy

· Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues

· Perform risk assessment or analysis

· Lead functional groups in the development of relevant data to complete a regulatory submission

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

• 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 
• Paid time off  
• 401(k) retirement savings with a generous company match 
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com  

Closely w/ R&D counterparts, US Regulations – (R&D – Klara’s Team – (Shihai)

Be able to Push back- good understanding- Molecular technology,