DIRECTOR REGULATORY AFFAIRS GLOBAL REGULATORY LEAD, GLOBAL REGULATORY STRATEGY
Company: Allergan
Location: Chicago
Posted on: November 13, 2024
Job Description:
Job Description
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- Director Regulatory Affairs Global Regulatory Lead, Global
Regulatory Strategy, responsible for developing and implementing
global strategies to secure and maintain market approval for
product(s) in the assigned therapeutic area.
- Responsible for leading the Global Regulatory Product Team
(GRPT), developing, and implementing global strategies to secure
and maintain market approval for product(s) in the assigned
therapeutic area.
- Continually expands TA knowledge and ensures strategic
messaging and content of global regulatory dossiers.
- May lead the Labeling Regulatory Strategy Team (LRST), and
serve as the primary regulatory interface with AST and supporting
teams.
- Manages compounds through all phases of development, including
post approval and throughout the life cycle of the product.
- Influences the development of regulations and guidance.
Analyzes legislation, regulations, and guidance and provides
analysis to the organization, with worldwide accountability for
assigned products.Qualifications
- Required Education: Bachelor's degree in life sciences
(pharmacy, biology, chemistry, pharmacology) or related
subject.
- Required Experience: 5-7+ years regulatory and drug development
experience.
- Proven 5+ years in a strategic leadership role with strong
project management skills.
- Preferred Experience: 7-10+ years' experience in pharmaceutical
regulatory activities, with experience as lead regulatory product
strategist in two or more major regions in addition to the US, such
as EU or Japan.
- Location: Preferred location is Lake County, IL
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Keywords: Allergan, Waukegan , DIRECTOR REGULATORY AFFAIRS GLOBAL REGULATORY LEAD, GLOBAL REGULATORY STRATEGY, Executive , Chicago, Illinois
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