AbbVie

Director, Global Regulatory Strategy I (Oncology)

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Dec 03, 2020
Ref
2009119
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, Global Regulatory Lead I, is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area in line with business objectives.

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 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. Regularly informs regulatory management of important timely issues and the impact on the global program.
  • Under direction of supervisor, provides executive management with meaningful regulatory measurements and regulatory opinion.
  • Develops, communicates and builds consensus for operating goals that are in alignment with the division. Under supervision of a GRL II or Therapeutic Area Head, creates and 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

Qualifications:
  • Bachelor's degree in (pharmacy, biology, chemistry, pharmacology) or related subject required
  • Relevant advanced degree is preferred. Certification a plus
  • 5+ years of regulatory experience. 10+ years in pharmaceutical industry, R&D or other related experience required. Proven 3-5 years in a leadership role with strong management skills
  • Experience working in a complex and matrix environment, and with multiple stakeholders.
  • Strong communication and proactive negotiation skills. Business acumen and able to work under pressure
  • 7+ years' experience in pharmaceutical regulatory activities preferred; preferably in at least 2 regions/major countries
  • Experience interfacing with government regulatory agencies. Experience working with Health Authority preferred
  • Experience developing and implementing successful global regulatory strategies preferred
  • Strong clinical foundation preferred


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 10 % 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.