Manager, Global Regulatory Applications & Product Lifecycle

Lake County, IL, US
Sep 19, 2019
Required Education
Bachelors Degree
Position Type
Full time
The Manager, Global Regulatory Applications and Product Lifecycle provides leadership and analysis of global regulatory submission records as relevant to AbbVie's technology solutions. Applies knowledge of regulatory framework in global markets to correctly identify records and applicability to current processes and standards. Incumbent will make decisions impacting global regulatory affairs business decisions. Act as primary liaison to internal customers regarding location of all submitted and approved regulatory dossiers, correspondence and status of same. Works appropriately with Business Technology Solutions and Area and Affiliate colleagues to solve simple and complex situations which impact our ability to report timely and accurate information regarding our product portfolio and regulatory status in country.

Key Responsibilities Include:

  • Develops strategies and identifies opportunities that may span multiple locations, functions or organizations related to Registration and Label Management systems such as TRACTS (The Registration and Compliance Tracking System) and GLS (Global Labeling System).
  • Conducts risk assessments and develops contingency plans to accommodate unforeseen events.
  • Monitors and participates in industry and agency initiatives around area of responsibility.
  • Provides direction to department staff. Provides direction and oversight on all projects within area of responsibility.
  • Interacts with all areas of regulatory affairs, affiliates and other departments within the greater pharmaceutical organization.
  • Develops, executes and implements business processes.
  • Responsible for assessment of metrics and reports to Senior Management on a monthly basis.
  • May have responsibilities for direct report employees or oversight of contract personnel. May indirectly manage the work of other department members.

Required Education:

Ÿ Bachelor's degree or High School diploma or equivalent and 10 years related experience.

Preferred Education:

Ÿ Bachelor's degree, RAC certification.

Required Experience:

Ÿ 5 years pharmaceutical or industry related experience.

Ÿ Experience working in a complex and matrix environment.

Ÿ Strong communication skills both oral and written.

Ÿ Experience/understanding/use of software tools.

Ÿ Proven leadership skills in a multi-disciplinary environment and presence.

Ÿ Keen awareness to cultural nuances; proven ability to work in a global environment.

Ÿ Strong attention to detail and problem solving skills.

Ÿ Ability to successfully interact with multi-divisional and multi-functional teams from across the globe.

Ÿ Ability to interact with senior management and executives.

Ÿ Effective use of negotiation skills to resolve issues.

Preferred Experience:

Ÿ Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area.

Ÿ Demonstrated analytical capabilities.

Ÿ 2 years of experience managing employees.

NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.