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AbbVieSenior Manager Regulatory Affairs, Global Reg Strategy US & Canada
AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead regulatory planning and execution for specific marketed products or developmental pipelines.…
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About This Role
AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead regulatory planning and execution for specific marketed products or developmental pipelines. Operating within a matrix environment, this position involves shaping regulatory tactics, compiling submission documents, and acting as the primary liaison with health authorities like the FDA. The organization focuses on discovering novel medicines across immunology, oncology, neuroscience, and aesthetics to address significant health challenges.…
Job Description
AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead regulatory planning and execution for specific marketed products or developmental pipelines. Operating within a matrix environment, this position involves shaping regulatory tactics, compiling submission documents, and acting as the primary liaison with health authorities like the FDA. The organization focuses on discovering novel medicines across immunology, oncology, neuroscience, and aesthetics to address significant health challenges.
This role suits professionals with a strong background in pharmaceutical regulations who excel at cross-functional negotiation and project management. The position operates on a hybrid schedule requiring three days on-site and two days remotely at company locations in Lake County, Illinois, Florham Park, New Jersey, or Irvine, California. Candidates must be comfortable with prolonged periods of continuous sitting during the workday.
Responsibilities
- Formulate and execute tactical and strategic regulatory plans for assigned products within specific therapeutic categories
- Serve as the primary agency liaison and communicate directly with the FDA for meetings, teleconferences, and briefing document preparation
- Partner with internal departments such as legal, clinical development, and public affairs regarding regulated communications
- Contribute to the compilation and review of regulatory filings to ensure compliance with Canadian and American guidelines
- Manage independent negotiations and decision-making processes for projects carrying cross-functional operational impact
- Aid in training and mentoring staff members while guiding difficult projects according to accurate regulatory interpretations
Requirements
- Minimum of six years working in research and development, regulatory affairs, or related pharmaceutical fields
- At least two to three years of direct experience executing pharmaceutical regulatory tasks
- Demonstrated ability to negotiate effectively, solve problems, and build consensus
- Strong written and oral communication skills suitable for cross-functional environments
Qualifications
- Bachelor degree in chemistry, biology, pharmacy, pharmacology, or a related industry discipline
- Advanced degree
- Relevant professional certifications
- Global regulatory experience
Core Skills
Benefits
- Paid time off including holidays, vacation, and sick leave
- Medical, dental, and vision insurance coverage
- Eligibility to participate in 401(k) plans
- Eligibility for long-term incentive programs
Frequently Asked Questions
What is the work schedule for this position?
This role follows a hybrid work model requiring three days in the office and two days working remotely.
Where are the reporting locations for this job?
Employees may work out of company offices located in Lake County, Illinois; Florham Park, New Jersey; or Irvine, California.
What level of experience is required to apply?
Applicants must have at least six years of general industry experience in research, development, or regulatory affairs, including a minimum of two to three years performing specific pharmaceutical regulatory activities.
Does the posting specify the exact salary for this role?
The posting does not state a specific salary, though it notes that eligible employees receive a comprehensive benefits package and long-term incentive program participation.
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