For The Candidates

Ra Manager - Clinical - Regulatory affairs - Pharm
Il
Type: Full-Time
Category: Regulatory Affairs
Job ID: 742
Opportunity Description:
( 847) Area code                                                                                 Chicago Area
 
 
Manager, Regulatory Strategy

Description

OBJECTIVES: 
  • Provides regulatory guidance and expertise to global project team on the assigned project(s) of responsibility.
  • Identifies regulatory requirements and data reporting deadlines to ensure registration and approval of drug products.
  • Plans/manage/execute all regulatory activities for lead compound(s) in development and supports regulatory activities for assigned marketed product(s) of responsibility.
  • Mentors and provides guidance to more junior regulatory personnel.
  • Provides regulatory support in FDA meeting preparation.
  • Interacts with the Project Management Staff at the FDA Divisional level.  May interacts with other levels of FDA within the Division(s) of responsibility
ACCOUNTABILITIES: 
  • Independently provides regulatory advice and guidance to the development team on most development issues.  
  • Plans, execute and manages regulatory submission for key compounds in various phases of development, including post-approval life cycle management activities for marketed products.
  • Ensure regulatory compliance of marketed products. 
  • Manages FDA meeting preparations. Acts as the lead regulatory representative at some FDA meetings.
  • Communicates with the FDA at the Division level and state regulatory agencies as required.
  • Provides input into the product development strategy and executes implementation.
  • Manages the preparation and submission of major regulatory submissions.
  • Provides input into regulatory risks assessment and makes recommendations relative to the overall strategy.
  • Manages others drug development regulatory professionals.

Qualifications

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 
  • BS/BA Degree and 8+ years of pharmaceutical industry experience to include 6+ years of increased regulatory responsibility. 
  • Master Degree and 7+ years of pharmaceutical experience including 5+ years of increasing regulatory responsibility.
  • Ph.D. and 5 + years of pharmaceutical experience including 3+ years of increasing regulatory responsibility.
  • Knowledge of FDA regulations. 
  • Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings.
  • Understanding of scientific principles and regulatory/quality systems relevant to drug development. 
  • Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for new product development.
  • Able to deal with issues of critical importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
  • Demonstrates problem-solving ability and generates alternative solutions prior to elevation of issues to Manager.
 
 
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