Posted:
9/20/2024, 1:19:09 PM
Location(s):
California, United States ⋅ Lake Forest, Illinois, United States ⋅ Illinois, United States ⋅ San Diego, California, United States
Experience Level(s):
Expert or higher ⋅ Senior
Field(s):
Legal & Compliance
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:
This position has primary management responsibility directly or through lower management levels for the preparation and submission of product approval applications. Works with regulatory agencies to obtain timely approvals of all products. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Ensures employee compliance with such policies, practices and procedures and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements
•Sets and executes effective RA strategy and directs preparation of submissions for products to regulatory agencies, and interfaces with agencies in order to obtain timely approval to produce and market new products.
•Provides guidance on regulatory requirements and strategies to product development project teams and MCSO.
•Maintains expert working knowledge of laws, regulations may impact company operations and decision making; communicates such knowledge to all internal stakeholders. Identifies risks inform how to reduce risk of non-compliance with current and pending regional product regulatory guidelines, rules, and regulations.
•Consults with and provides advice to senior management of the division on strategies and plans for regulatory product approvals. Work closely with MCSO, R&D, Quality, and Marketing teams to align regulatory activities with business objectives.
•Directs staff in implementing regulatory strategy and preparing regulatory submissions.
•Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
•Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
•Performs related functions and responsibilities, on occasion, as assigned.
•Supports all business segment initiatives as identified by divisional management and in support of RA strategy for NPI and other regulatory requirements.
•Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
•Serves as an influential spokesperson with FDA staff , including leading meetings and preparations to facilitate expedited approval of original applications and supplements.
•Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees.
* 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: 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.
The base pay for this position is
$162,000.00 – $324,000.00In 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
Website: https://abbott.com/
Headquarter Location: Illinois City, Illinois, United States
Employee Count: 1001-5000
Year Founded: 1944
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Emergency Medicine ⋅ Genetics ⋅ Health Care ⋅ Health Diagnostics ⋅ Manufacturing ⋅ Medical ⋅ Medical Device ⋅ Nutrition ⋅ Pharmaceutical