Regulatory Affairs Team Lead

Posting Date 1 week ago(7/20/2021 4:55 PM)
Requisition ID
2021-9315
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Inc.
Category
Regulatory Affairs

Overview

The Regulatory Affairs Team Lead manages the workload of the Regulatory Affairs Specialists and Regulatory Affairs Technicians within an assigned product area or regional area to help ensure the process produces effective regulatory submissions and timely regulatory approvals.

Responsibilities

• Ensure workload and workflow of assigned regulatory area is optimized
• Communicate status of projects directly to RA Management and other
stakeholders
• Actively pursue ways in which to improve the function of the Regulatory
Affairs Department
• Monitor the progress of RA team members on assigned tasks, and
remove roadblocks
• Review submissions generated for their assigned regulatory area
• Communicate directly with regional regulatory agencies and distributors
to ensure product clearances are achieved in a timely manner
• Work with Management to allocate resources sufficient to complete
projects in a timely manner
• Provide direction and logistical support to the RA team members to
complete assigned tasks
• Foster accountability within the team to meet established timelines

• Mentor and train new RA team members
• Must work and interact effectively and professionally with and for others
throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and
independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

Qualifications

• Minimum 1 year direct regulatory affairs or equivalent experience
• Proven project management and supervisory skills
• Bachelor’s degree in business, life science (preferably biology or
chemistry), engineering, or other related field (such as law); or
experience of such kind and amount as to provide a comparable
background

Certification or commensurate experience

 

Physical Requirements:

• General office environment
• Sits for extended periods
• Requires close visual acuity when working with computers, etc.
• Requires occasional early morning or late evening teleconferences
• International and domestic travel as required

• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.  

 

**Qualified candidates must be legally authorized to be employed in the United States.  Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**

 

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