Job Description

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 107,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION:

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.

Abbotts life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. Were 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 Abbotts diagnostics instruments, providing lab results for millions of people.

Abbott Molecular has an opening in its Des Plaines, IL site for 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 YOULL 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, YOULL 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

JOB FAMILY:

Regulatory Operations

DIVISION:

CHMN Office of the Chairman

LOCATION:

United States > Des Plaines : 1350 East Touhy Avenue

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf