AbbVie

Director, Global Regulatory Lead (General Medicine)

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Aug 24, 2020
Ref
2004646
Required Education
Bachelors Degree
Position Type
Full time
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 Director Regulatory Affairs Global Regulatory Lead in Global Product Strategy is responsible for developing and implementing global, US and Canadian regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT), ensures strategic messaging in global, US and Canadian regulatory dossiers under guidance of management. Manages compounds through all phases of development, post approval and life cycle of the product. Manages products and change control in compliance with regulations, company policies and procedures. Delivers global, US and Canadian regulatory product strategies to ADT. Demonstrates leadership behaviors consistent with level. May participate in initiatives.

Responsibilities:

  • Leads a team of regulatory professionals who develop strategy for development and marketed products.
  • Ensures inclusion of strategic messaging in the content of global regulatory dossiers. Seeks expert advice and technical support when necessary from Director and TAH level personnel.
  • Leads preparation and maintenance of global, US and Canadian regulatory product strategies. Under guidance of supervisor, leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
  • May participate in regulatory and Company initiatives and contributes to the performance management for other Regulatory Affairs team members.
  • Influences the development of regulations and guidance. Analyzes legislation, regulation and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
  • Under supervision, advises internal personnel on regulatory strategies. Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department.
  • Under direction of supervisor, provides executive management with meaningful regulatory measurements and regulatory opinion.
  • Works with GRPT to develop, communicate goals that are in alignment with the business goals. Under supervision of a Director level GRL or TA Head, communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management.
  • Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
  • Follows budget allocations and keeps supervisor informed on project resourcing


Qualifications
  • Required Education:Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
  • Preferred Education:Relevant advanced degree is preferred. Certification a plus
  • Required Experience:5+ years of regulatory experience. Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US&C region.Proven 3-5 years in a leadership role with strong management skills.
  • Experience working in a complex and matrix environment, and with multiple stakeholders. Experience interfacing with government regulatory agencies. Experience working with Health Authority
  • Strong communication and proactive negotiation skills. Business acumen and able to work under pressure
  • Preferred Experience:7+ years' experience in pharmaceutical regulatory activities; preferably in at least 2 regions/major countries.Experience developing and implementing successful global regulatory strategies.Strong clinical foundation preferred.Note: Higher education may compensate for years of experience

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 25 % 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.