Associate Director/Director Regulatory Operations | BioNJ Talent Services

Associate Director/Director Regulatory Operations

Contact Information
Contact Name: 
PIERRE-PAUL DEPELTEAU
Organization Name: 
YourEncore
Position Location: 
Princeton, NJ
Contact Phone: 
609-751-9898
Company Profile: 

YourEncore, a subject matter expert consulting company, works with biopharma and medical device companies in clinical development, medical affairs, regulatory, drug safety, quality, compliance and manufacturing.

Founded in 2003, YourEncore today works with leading global pharmaceutical and medical device companies, as well as smaller biotech and startup companies. For more information, visit www.yourencore.com and follow www.facebook.com/yourencore.

If you interested in being considered for consulting opportunities, please enroll in YourEncore at https://careers.yourencore.com

Job Description:

Our global pharma client, seeks an expert to assist with Regulatory Operation submission management and document publishing. Critical support functions need to be established.

The following processes need to be established:

IND (including transfer, initial, and maintenance)
Initial Investigator Brochure (IB)
IB Updates
Global Reg Affairs Management Plan (RAMP) Development; address EDS process
Pediatric Investigator Plans (EU)
Pediatric Study Plans (US)
Rapid Response Process to Health Authority Queries
Writing process and best practices
Aggregate Reports, including periodic safety updates, SAE & narrative processing
Global CTA process
China Reg Activities (CTA development)
CTA Core Documents
CTA Exceptions (Brazil, Canada, Others)
Japan Reg Activities (CTN development)
Special Submissions (Fast Track, Orphan Applications, BTD, AA, Priority Review)
Health Authority Interaction Plan (background doc, slides, HA meeting prep/management)
Communications with Local Medical, Clinical, and Regulatory
NADIA/BOLA Submissions
MAA Submissions
Other Marketing Submissions (e.g., ROW MAAs)
Regulatory Information Management
IMP Labeling review
IRB/EC Submissions and Approvals & Updates
Informed Consent Form

Full time (40 hours per week)

Can work remotely most of the time, but candidate should live close to Princeton, NJ to work onsite 1 to 2 days a week

Approximate start date: 11/27/17

Qualifications: 

The client is looking for a candidate with deep regulatory operations knowledge who understands what the key elements are, can ask the right questions, document process and can facilitate review.
Prior experience setting up a Regulatory Operations function at a small company. Possesses experience listing out processes that need to be completed.

Additional Job or Internship Information
Position Type: 
Contract
Function: 
Regulatory Affairs
Job Reference: 
Job 11896
Application Deadline: 
11/17/2017
Number of Openings: 
2
Length in Months: 
10
Paid: 
Yes
Salary: 
TBD based on qualifications