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Head of RA Medical Devices and Combination Products- Pharma

Employer
AbbVie
Location
Lake County, Illinois
Start date
Sep 3, 2021

View more

Discipline
Science/R&D, Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

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.

The Head of RA Medical Devices and Combination Products- Pharma combines knowledge of scientific regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Leads a team of global regulatory professionals who develop strategy for development and marketed products, and manage the content of global regulatory dossiers. Exercises division and corporate level influence and is considered a key opinion leader and expert resource. Influences the development and changes for regulations and guidance, interfaces with outside regulatory agencies and acts as an advisor/liaison to senior management in order to plan, evaluate, and recommend regulatory strategy. Directs the development of strategy and organizational structure to ensure product promotions, global registration of products, processes and facilities and maintenance of products and processes in regulatory compliance.

  • Works under consultative direction to obtain long-range goals and objectives. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results. Work most often checked through consultation and agreement with others rather than by formal review of superior.
  • Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments; may be asked to evaluate performance of and assist in career development planning for subordinates.
  • Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
  • Advises management of the effect of current, newly finalized or proposed laws, regulations, guidelines and standards, and on advisory committee recommendations.
  • Develops, communicates, and builds consensus for operating goals that are in alignment with the division
  • Provides leadership to organizational staff by communicating and providing guidance towards achieving department objectives. Advises internal personnel on regulatory strategies
  • Creates immediate to long-range plans to carry out objectives established by executive management
  • Participates in the development of a budget for a department or group to meet organizational goals. Forecasts future departmental needs including human and material resources and capital expenditures
  • Recommends modifications to the structure of organizational units or a centralized functional activity subject to senior management approval.
  • Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management

Qualifications
  • Bachelor's degree (pharmacy, biology, chemistry, pharmacology) related life sciences Preferred Education: Relevant graduate degree; Strong clinical foundation
  • 15+ years industry related experience Preferred
  • 10 years in quality systems and process improvement preferred
  • Proven 10+ years in a leadership role with strong management skills preferred
  • Experience working in a complex and matrix environment
  • Strong communication skills, both oral and written
  • Strong business acumen and negotiation skills
  • Experience developing and implementing successful global regulatory strategies
  • Interfacing ability with government regulatory agencies.
  • Experience working with Health Authority

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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