Abbott
Medical Devices & Equipment
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Regulatory Affairs Project Manager
About Abbott
Our nutrition business develops science-based nutritional 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 lives.
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
The Opportunity
This position works out of our Abbott Park, IL location in the Nutrition Division.
What You’ll Work On
Primary Function/Primary Goals/Objectives:
1. Combine knowledge of scientific, regulatory and business issues to enable Abbott Nutrition products to meet required legislation.
2. 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.
3. Identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance.
4. Identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.
5. Utilize technical regulatory skills to propose strategies on complex issues.
Major Responsibilities:
1. Responsible for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents.
2. Responsible for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
3. Provide regulatory input to product and/or packaging lifecycle planning and in all stages of product and/or packaging development.
4. Anticipate regulatory obstacles and emerging issues throughout the product and/or packaging lifecycle and work with appropriate teams to develop solutions.
5. Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
6. Interpret and apply regulatory requirements.
7. Monitor and influence external environment for impact on company products/business activities (e.g., regulation changes, government practices, trade association activities, etc.).
8. Recruit, develop and mentor regulatory professionals.
9. Maintain regulatory data in electronic systems.
10. Depending on specific role, the Regulatory Affairs Project Manager may be involved in various regulatory activities (market access activities, regulatory submissions/registrations; evaluation of product and/or packaging and manufacturing changes for regulatory implications; maintaining compliance documentation,; review and approval of label changes, advertising and promotional items; oversight of systems related to product and/or packaging management, project management, process improvement, etc.).
Supervisory/Management Responsibilities (Influence/Impact/Leadership):
1. 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.
2. Develop, communicate, and build consensus for operating goals that are in alignment with the division.
3. Provide leadership by communicating and providing guidance towards achieving department objectives.
4. Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
5. Perform work without appreciable direction.
Accountability/Scope:
1. Execute and manage technical and scientific regulatory activities.
2. Function independently as a decision-maker on regulatory issues and assure that deadlines are met.
3. Effectively communicate, prepare, and negotiate internally and externally with key stakeholders, various regulatory agencies, trade associations, etc.
4. Create immediate to long-range plans to carry out objectives established by top management.
EDUCATION AND EXPERIENCE, YOU’LL BRING
Required
Note: Higher education may compensate for years of experience or vice versa.
Preferred
Other skills:
a. Strong attention to detail.
b. Create and manage project plans and timelines.
c. Manage multiple and competing priorities.
d. Think analytically; creatively solve problems; organize and track complex information.
e. Plan and conduct effective meetings.
f. Proficient computer skills.
MISC:
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
$99,300.00 – $198,700.00In specific locations, the pay range may vary from the range posted.
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
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