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Associate Director/Director, Regulatory Affairs

Company Name:
The JordanSpenser Group, Inc.
Associate Director/Director, Regulatory Affairs
US and Canada
Key Responsibilities Include:
Candidate will be responsible for contributing to and implementing strategies to support assigned projects within US Marketed Products
Review, compile, and submit variations, new applications, supplements and amendments and periodic reports, as well as responses to Health Authorities as needed
Development, defense, and implementation of robust Regulatory Strategy and Tactical plan for assigned projects
Responsible for managing complex issues and providing leadership to assigned teams
Responsible to ensure regulatory commitments are met for assigned projects
Independently manages projects, product assignments and is responsible for managing timelines with minimal supervision
Provides recommendations and guidance on project decisions and makes recommendations for improvements
Steers projects and communicates to manager any issues that would result in a delay
Communicate directly with FDA as a company liason
Effectively negotiate regulatory agreements with Health Authorities
Qualifications
Basic:
Bachelor's Degree (or equivalent)
5-10 years experience in a regulated industry (e.g., pharmaceutical, pharmacy). Regulatory area is preferred but may consider other related area. Note: Higher education may compensate for years of experience.
Preferred:
Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. Advanced degree (MS)
5-10 years of experience in regulatory preferred
Key Competencies:
Strong negotiation skills, oral and written communication skills, and influencing skills to ensure completion of assigned tasks
Self-Motivated, independent thinker, able to work remote from direct manager
Level of position commensurate with experience

For more information about this opportunity, please contact:

David Alvarado
Managing Director
631.706.4443
http://www.linkedin.com/in/pharmarecruiter



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