For The Candidates

Ra Assoc. Director/Director - Clinica/Strategy - Regulatory Affairs -Pharma
Il
Type: Full-Time
Category: Regulatory Affairs
Job ID: 745
Opportunity Description:
(847) Area code                                                                             Chicago area
 
 
 
Associate Director / Director Regulatory Affairs Strategy

OBJECTIVES: 
  • Provides regulatory strategic direction for the global development and implementation of regulatory activities for one or more projects.
  • Responsible for multi-disciplinary or multi-faceted development programs (i.e. multiple indications for a given compound).
  • Supervises trains and provides technical and regulatory guidance to staff.
  • Provides regulatory therapeutic area strategic guidance on development projects and marketed products.
  • Develops regulatory development plans and manages plan execution.
  • Represents the company at regulatory meetings.
  • Interact with all levels of FDA within the Division(s) of responsibility
 
ACCOUNTABILITIES: 
  • Provides strategic direction for the global development and implementation of regulatory strategies for the products of responsibility.
  • Provides oversight to ensure regulatory compliance of marketed products. 
  • Provides strategic direction for FDA meeting preparations, including FDA Advisory Committee Meetings.
  • Negotiates regulatory issues with the FDA at the Division level and state regulatory agencies as required.
  • Provides product development strategy and manages the implementation of regulatory strategies to meet project goals for specific drug development projects.
  • Provides regulatory leadership for the preparation and submission of major regulatory submissions.
  • Evaluates regulatory risks for projects and make recommendations relative to the overall program strategy.
  • As assigned is responsible for "due diligence" and feasibility assessment of drug development candidates.
  • Manages others drug development regulatory professionals.

Qualifications

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 
  • BS/BA Degree required.
  • Master's or other advanced degree preferred.
  • 10 years of experience in the pharmaceutical industry or regulatory agency experience.
  • 8 years of regulatory experience.
  • 4 years of progressive management experience.
  • Knowledge of FDA regulations and global regulatory environment.
  • Previous experience in drug development.
  • Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for new product development.
  • Functions independently as a decision-maker on regulatory issues.
  • Understands regulatory, quality and safety systems impacting drug development and marketed product support.
 
If you are interested in the company name and exact location
for this opportunity, please enter your email address below.

Get In Touch With Us

Client Testimonials

"My confidential career search was handled with respect and they listened to what I wanted. I moved from New Jersey to Colorado with help from InVision Inc."

"I have never seen this quality of talent assembled for a Regulatory Vice President opening. Regulatory staffing is very unique. InVision produced great results in a short amount of time."

"I called InVision on a Tuesday morning with a very unique regulatory opening and they presented (4) qualified candidates in 3 days... We hired the second person they submitted. Results! Thank You"

"The staff at InVision prepared me for a great interview and guided me along the interview process step by step. Unique niche recruiters have come and gone InVision has been around for years and having RA/QA knowledge really helps."

"Your friend Paula should contact the world's greatest RA and QA recruiting company, InVision I can serve as a reference if needed."

"I sent InVision my regulatory resume looking to relocate to California and they presented (2) director level openings right away and they followed up with me. Feedback from my resume really helped."