Supervisor, Regulatory Operations

Employer
Premier Research - USA
Location
United States; Homeworking
Salary
Competitive
Start date
19 Jan 2023
Closing date
18 Feb 2023

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

  • Manage, publish, and QC all components of medium to large, moderately complex Regulatory Agency submissions, including INDs and amendments, NDA/BLAs and supplements, annual reports, safety reports, etc.
  • Provide Regulatory Operations guidance and information to the Regulatory Affairs department and sponsors, as applicable
  • Mentor and train Regulatory Operations team members
  • Supervise and guide Regulatory Operations personnel and workload to ensure timely deliverables
  • Can participate in the implementation, migration, maintenance, and upgrade of regulatory systems and tools (e.g., EDMS, templates, and publishing systems)
  • Supervise or participate in software update implementation, in conjunction with IT and management, and/or publishing application provider, in a timely manner
  • Participate in the interpretation and implementation of new health agency guidelines and rules relevant to regulatory submissions
  • Prepare, maintain and/or participate in the writing and reviewing of Regulatory Operations work practices
  • Coordinate and/or format complex submission level documents, utilizing internal processes and tools, to ensure electronic submissions meet required standards and technical requirements within specified timelines

Company

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a team of more than 2,000 people in 20+ countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. 

We are more than a company – we are a community of people that truly care about one another, our clients, and our mission of furthering research to improve the lives of patients in critical need. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. As a Premier team member, you have the power to make an impact, regardless of job title and location.  

 

Find Us
Website
Telephone
+1 919 627 9100
Location
3800 Paramount Pkwy
Suite 400
Morrisville
NC
27560
US
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