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Senior Director EU Regulatory Strategy - Charles City, United States - Regulatory Connect
2 weeks ago
Description
1 day agoBe among the first 25 applicants
Direct message the job poster from Regulatory Connect
Putting the right people in a position to make a difference.
Senior Director Regulatory Affairs- EU Strategy(East Coast candidates only)
At Regulatory Connect, we are thrilled to announce our strategic partnership with an innovative and forward-thinking biotechnology company. Our partner is passionately committed to revolutionizing treatment through groundbreaking drug discovery and the development of next-generation medicines.
As a member of our partner's Regulatory Affairs team, you will have the unique opportunity to report directly to the Head of Regulatory Affairs.
In this influential role, you will play an integral part in shaping the regulatory strategy for EU submissions. Your primary role will serve as primary liaison to the EMA for an upcoming MAA .This role serves as European Regulatory strategist and is responsible for proactively developing and executing regulatory strategy in EU.
Your contributions will be pivotal in advancing cutting-edge therapies and you will spearhead an upcoming MAA as well as earlier programs.
What is required:
Recent hands-on experience with leading preparation of a Centralized MAA in EU.
Direct experience leading formal meetings with EMA and other European health authorities.
Familiar with EMA content and technical requirement for MAA/CMA submissions.
Experience developing and implementing regulatory strategies for EU MAA and CTR.
Accomplished in leading cross-functional teams and managing timelines.
Seniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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