Regulatory Submission Manager | BioNJ Talent Services

Regulatory Submission Manager

Contact Information
Contact Name: 
Pierre-Paul Depelteau
Organization Name: 
YourEncore
Position Location: 
Lawrenceville, NJ
Company Profile: 

THE EXPERTS
ON EXPERTS.

WE PROVIDE CUSTOM SOLUTIONS TO FLEXIBLY ENGAGE HIGHLY EXPERIENCED TALENT FROM OUR EXPERT COMMUNITY FOR CLIENTS IN PURSUIT OF HELPING THE WORLD LEAD HEALTHIER, SAFER, RICHER LIVES.

Job Description:

Job 12015 Regulatory Submission Manager (Contract Position)

We are looking for a Regulatory Submission Manager for the contract position described below:
Location:
• Lawrenceville, NJ

Description:
• Execute preparation and submission of CLIENT global regulatory dossiers
• Determine submission content and execution strategy
• Lead project sub teams to ensure the execution of submissions
• Produce the table of contents for submissions and ensuring the completion of the submission
• Contribute to CLIENT policies/procedures required to ensure the validated execution of submissions
• Track documentation/components for dossiers
• Operate as the functional area expert in terms of dossier production, provides direction, fosters effective team skills, and drive results
• Participate in the development/review of health authority policy (REACT Teams)
• Ensure dossiers meet electronic regulatory submission requirements
• Provide Global Dossier Management input for regulatory submissions strategy

Qualifications: 

Qualifications:
• BS, MS or Ph.D with minimum 4 years of pharmaceutical experience, including 2 years in regulatory
• Knowledge of drug development process and regulatory dossier development/management
• Knowledge of US/European regulatory processes, ICH regulatory submissions, electronic submission, dossier publishing tools and submission validation procedures
• Familiar with Microsoft Office, Outlook, Communicator, Access, Documentum, eCTD viewers and web based applications
• Knowledge of global regulatory practices, electronic submission guidelines and requirements by planning, managing and overseeing the operational aspects of the production of submissions across various therapeutic areas/submission types (IND, BLA, NDA, Safety, etc.)

Timing:
• 40 h/w
• Start: 02/05/18
• End: 06/29/18

If you interested in being considered for this engagement, please enroll in YourEncore at http://careers.yourencore.com If not, is there someone you would recommend for the project?
We look forward to hearing from you, and please contact me if you have any questions.
Thanks and Regards,
Pierre-Paul Depelteau
Talent Acquisition at YourEncore
pierre-paul.depelteau@yourencore.com

Additional Job or Internship Information
Position Type: 
Contract
Function: 
Regulatory Affairs
Application Deadline: 
02/01/2018
Number of Openings: 
2
Length in Months: 
5
Paid: 
Yes