Skip to main content

Search jobs

Search jobs

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Principal Scientist II, Analytical Strategy & Regulatory Intelligence- ARD

North Chicago, Illinois Req ID 2207462 Category Research and Development Division AbbVie

Primary function:

  • Regulatory strategy liaison with global Analytical R&D (ARD) project teams including timely communication of applicable regulatory intelligence while advising/supporting project teams to ensure consistent application of internal processes
  • Drive a cohesive control strategy and specification approach for NCE portfolio programs, mentoring/coaching teams via CSR/SAT process
  • Act as single point of contact for ARD project teams in QDP audit process: interfacing with QA auditors, supporting document roadmap compilation, resolving issues/observations and process improvements
  • Evaluate and translate regulatory feedback into practical knowledge by authoring internal guidance documents, procedures, work instructions, and white papers to support ARD’s business 
  • Identify and execute initiatives that streamline and simplify ARD’s analytical and regulatory processes in support of a diverse development portfolio while coordinating broad internal CMC stakeholder alignment

Management & Development of People / Resources:

  • Individual contributor role responsible for mentoring junior colleagues, interns, and summer workers

Innovation & Scientific Leadership:

  • Contribute to ARD global regulatory policy review and region-specific implementation strategies with broad internal CMC stakeholder reach on topics including analytical method development, validation, and transfer; specifications and control strategies; stability testing; and review and implementation of compendial changes. 
  • Maintain ARD regulatory intelligence information capabilities
  • Understand and consolidate global ARDs interests / needs on regulatory and data strategy topics
  • Develop creative ideas to make external and internal guidance documents, procedures, work instructions, and white papers etc. available and implemented to ARD project teams
     
Qualifications:

Minimum Education & Experience Required:

  • Bachelor’s + 14 years, Master’s + 12, PhD + 6 years in pharmaceutical sciences, chemistry, food sciences or related field is required. Advanced degree is preferred.
  • Must have a thorough understanding of small molecule (NCE) analytical development and deliverables required to support end-to-end pipeline programs.
  • Flexibility and ability to look/think outside-the-box for new ways to work in ARD based on changing external regulatory landscapes and industry trends.
  • Exhibit passion and energy to build consensus, overcome resistance, and drive change (be a change agent) within ARD and across a broad cross-functional stakeholder group while embracing a global mindset.

Leadership competencies:

  • Builds strong relationships with peers to create and implement cross-departmental analytical strategies.
  • Knows the business to influence long-range analytical strategy.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Deals comfortable with uncertainty, ambiguity, and risk to make decisions having mid-term impact. Ensures alignment with corporate/regulatory policies/standards.
  • Steps up and takes leadership to implement changes in the face of organizational or personal challenges.
  • Raises the bar and drives the function to efficient/reliable execution.
  • Learns fast, grasps the essence and can change course quickly where indicated to manage and prioritize resources & timelines across a wide range of development programs/scientific initiatives within area of responsibility.

*Job level will be commensurate with academic and work experience.*

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Research and Development, North Chicago, Illinois, United StatesRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation