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Associate Director, US & Canada Regulatory Strategy

Employer
AbbVie
Location
Lake County, IL, US
Start date
Oct 15, 2019

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Discipline
Marketing, Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
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Job Details

Key Responsibilities Include:
  • Makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Operates independently, with recognition of when to consult senior concerning risks.
  • Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs.
  • Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities. Uses knowledge of global marketplace, technology and business levels effectively.
  • In absence of Director, is responsible for day-to-day operations, and departmental initiatives, which have impact on both internal and external customers. Encourages innovation and delivers on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development.
  • Represents A&A on Global Regulatory Product Team (GPRT) and ADTs as appropriate. Advises on regional requirements and provides strategic input.
  • Serves as Health Authority liaison and collaborates with Health Authority for meetings, teleconference, etc. Coordinates preparation of Health Authority meeting briefing packages.
  • Proven understanding of regulations and mentorship of regulatory authorities, political and legal climate and industry practices to assist in meeting interpersonal goals. Possess and demonstrates broad industry knowledge.
  • Leads communication with Health Authority for key projects/issues, including negotiation with review division personnel. Coordinates and prepares submissions in line with Health Authority regulatory requirements and guidelines.
  • Balances the preparation and review of submissions to assure effective presentation of data, complete and timely response to Health Authority during application review.
  • Assists in the development, training, and mentoring of staff members.


  • Required Education: Bachelor's Degree (pharmacy, biology, pharmacology) or related life sciences
  • Preferred Education: Advanced degree or Certification is a plus!
  • Required Experience: 8 years Regulatory, R&D or industry related experience
  • Extensive experience working with government Agencies and Health Authority personnel. Experience working in a complex and matrix environment
  • Proven success in negotiation skills, critical thinking, and credibility within the organization. Strong interpersonal skills, both oral and written
  • Preferred Experience: 5 years in regulatory pharmaceutical affairs
  • Strong leadership presence with prior management experience
  • Experience developing and implementing successful global regulatory strategies

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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