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Job Title: Regulatory Controls Director
Location: Illinois, Chicago
Discipline: Regulatory
Reference: CMMQ5981
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Description:
CMMQ5981
Regulatory Controls Director
Chicago, IL
Ensures development and execution of Latin America Affairs
regulatory strategies for new registrations and maintenance of existing
business, aligned with (LAA) Latin American Affairs business needs and
dynamic regulatory environment. Responsible for resolving
issues with Area Commercial, including resource allocation
and prioritizations. Will provide full regulatory support across
LAA markets and support new opportunities in key emerging
and established markets. Manages Area processes to consolidate
regional LAA input into R&D Programmes. Effective working relationships
with LAA national Affiliate Regulatory managers are critical to the
success of this role. Manages the Area processes to achieve
regulatory approval in conjunction with national Affiliate regulatory
managers in the region. Maintains an awareness of Area legislation
and assesses its impact on the comapny's business and product
development programmes. Proactively briefs impacted groups i.e.
Development regulatory, CMC regulatory and Commercial. Proposes
new/revised policies and recommends standard interpretation of Area
regulations. Management of high profile/high criticality regulatory issues
and
communications, including those impacting business strategies. Identify and
communicate potential global considerations. Accountable to management for
development and execution of regulatory strategies and all actions
required to maintain the business, including compliance with changing
regulatory requirements and business/industry environment.
Accountable to Divisional Vice President, International Regulatory
Qualifications: Minimum Requirements Basic Qualifications:
-Bachelor degree in pharmacy, biology, chemistry,
pharmacology, or related subject.
-12 years pharmaceutical industry experience in regulatory affairs, strong
management skills.
-Fluency in Spanish highly desirable
-Strong interpersonal skills.
-Strong hands-on experience of LAA Regulatory legislation and awareness of
current trends.
-Well-networked with regional Regulatory agencies
-Proven negotiating and delegation skills.
-Effectively develops personnel.
-Understands business needs and impact of regulatory issues on these.
-Directs technical writing for impact.
-Travel 30-40%
***Additional Plus' Desired
- European language skills - desirable
-Master's degree or higher preferred
Apply to: Click Here
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