Job Overview
Company:
Base Pay:
Other Pay:
Employee Type:
Industry:
Manages Others:
Job Type:
Required Education:
Required Experience:
Required Travel:
Relocation Covered:
Reference ID:
Location:
Contact:
Phone:
Email:
Fax:
 
 
 

Company Overview

Fairway Consulting Group is a leading executive search firm dedicated to the pharmaceutical, biotechnology, and medical device industries. We represent a wealth of opportunities with our clients who are located across the United States and around the world. We welcome receiving your industry-related resume or CV for this or other positions. Please visit our website at www.fcgsearch.com to learn more about us.


Learn More about Fairway Consulting Group
Visit our Website

Regulatory CMC Liaison / Biologics    Apply for this job now!
Report It

Job Description

Regulatory CMC Liaison / Biologics

 

Our client is a leading global pharmaceutical company.  They have asked us to assist them in their search for candidates to fill role of Regulatory CMC Liaison – Biologics. 

 

The successful candidate will:

 

  • Provide biologics-specific regulatory advice and creative solutions to fellow members of the Regulatory CMC Group, based on his/her wealth of experience 

  • Formulate, lead and drive regional and/or global CMC regulatory biologics strategy for assigned development projects and/or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance. 

  • Proactively provide strategic input and communicate critical topics in adequate and timely manner to interdisciplinary project teams and to appropriate management level. 

  • Lead, implement and drive CMC submission activities (planning, review, coordination, submission) for assigned projects/products. Make quality regulatory decisions as necessary, balancing risks and benefits. 

  • Represent Regulatory CMC in interdisciplinary regulatory and technical project teams. 

  • Establish and maintain a single point of contact with internal and external partners and customers for all communication on development projects and marketed products. Establish and maintain sound working relationships with partners and customers. 

  • Lead cross-functional Health Authority response teams for assigned development projects, as appropriate.

 



Job Requirements

We seek candidates who meet these minimum requirements:

 

  • Relevant 4-year scientific degree in biotechnology, biochemistry and cell biology or equivalent. 

  • 7-10 years of experience in regulatory preferred. 

  • Excellent working knowledge/experience in regulatory submissions and approval processes for Biopharmaceuticals and ability to deal with complex CMC regulatory issues and requirements 

  • Strong background in biopharmaceutical development (e.g. cell culture, downstream processing, analytics). Biologics experience desired.

  • Proven track record in successfully leading/working in interdisciplinary teams, and in planning, coordinating and leading activities simultaneously on multiple projects. 

  • Strong interpersonal, organizational, communication, presentation, negotiation and problem solving skills. 

  • Fluent English language skills, oral & written.

 

Do you have the skills and experience we seek and want to advance your career with a leading company?  If so, please email your resume as a Word attachment to [Click Here to Email Your Resumé] , reference code 2360-CB.  No calls or faxes, please.  Include your daytime phone number and we will contact you confidentially or reply to your email.

 

     Apply for this job now!
Report It


CareerBuilder.com's Advice

For your privacy and protection, when applying to a job online:
Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.  Learn More >>

By applying to a job using CareerBuilder.com you are agreeing to comply with and be subject to the CareerBuilder.com Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.
Register