Abbott Project Manager Regulatory Affairs in Abbott Park, Illinois
At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Primary Function/Primary Goals/Objectives :
Combine knowledge of scientific, regulatory and business issues to enable Abbott Nutrition products to meet required legislation. Have department/group/site level influence and be generally recognized as an expert resource within the department. May also share knowledge and expertise with others in support of team activities. Identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance. Identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Utilize technical regulatory skills to propose strategies on complex issues.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents.
Responsible for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
Provide regulatory input to product lifecycle planning and in all stages of product development. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions. Assist in the development of multi-country regulatory strategy and update strategy 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 mentor regulatory professionals. Maintain regulatory data in electronic systems.
Depending on specific role, the Regulatory Affairs Project Manager may be involved in various regulatory activities (regulatory responsibilities for clinical trials; regulatory submissions; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings and patent information; review and approval of label changes, advertising and promotional items; oversight of systems related to product safety issues and product recalls, project management etc.).
Supervisory/Management Responsibilities (Influence/Impact/Leadership):
Provide leadership without direct authority (i.e., project leader) and provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments.
May mentor other department members.
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 on significant matters, often requiring the coordination of activity across organizational units. Perform work without appreciable direction.
Bachelor's degree (or equivalent) is required - preferred area of focus in science (biology, chemistry, nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, and 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.)
- 2-5 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area. 4-5 years of experience in a regulated industry (e.g., nutritionals, medical products).
Note: Higher education may compensate for years of experience or vice versa.
Regulatory knowledge of (as applicable):
Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc.
GxPs (GMPs, GLPs, GCPs).
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.
Evaluate various technical alternatives and perform risk assessment and analysis.
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.
Execute and manage technical and scientific 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.
AN Abbott Nutrition
United States > Abbott Park : AP06C Floor-4
United States > Columbus : 2900 Easton Square Place
Yes, 10 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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