Regulatory Operations Submissions Manager - OneSource Regulatory

Join the OSR Team to transform Regulatory Operations project submission management and the way you work.

About OneSource Regulatory

OneSource Regulatory™ helps companies implement the correct solutions, processes, standards, systems, templates, and best practices for effective Regulatory Operations.  With the right Regulatory Operations group, our clients can achieve high quality document management, data management, and regulatory agency submissions.

  Today we provide the following exemplary operations services:

• Regulatory Operations service provider to over 100 small to large sized companies
• Process Optimization
• System Implementations
• Document Management
• Submission Management
• Publishing
• Archiving
• RIM
• Submission Managers
• Publishers
• Fully Outsourced Regulatory Operations

Experience in pharmaceutical, biotechnology, medical device, nutritional supplements, animal health and cosmetic products

Collaborative professionals who file applications for new brands as well as maintain growth and legacy products

We hire the best, most experienced and collaborative experts in the industry and ensure that they have the latest resources and technology solutions.

• Work from anywhere
• Competitive salary & innovative incentive programs

What You’ll Do

Do you want the opportunity to work with a diverse group of pharmaceutical companies and provide publishing support for some of the most innovative products in the industry - from the comfort of your home?

OneSource Regulatory (OSR), is seeking qualified Regulatory Operations Submission Management professionals based in the US.  You should be a collaborative team member who provides planning and execution of regulatory submissions (clinical trial applications, HA meeting packages, NDA/MAA) for several client products through effective interaction with submission teams, Regulatory Leads, and the OSR Regulatory Operations Director.  You should have a strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.

The OneSource Regulatory team is comprised of the top experts in Regulatory Operations.  OSR team members have an average of 15 years of industry experience in large, mid-size and small companies across every therapeutic area.

At OSR, you will be offered interesting and challenging work, and your position will come with a competitive salary, a flexible schedule and innovative incentive programs that reward your contributions and innovations.  You will have the opportunity for personal and professional development through internal coaching and mentoring, in addition to the opportunity to attend key external events.

Learn more about OSR by visiting our website:  www.OneSourceRegulatory.com

Questions?  Email us at info@OneSourceRegulatory.com

Interested in joining the OSR Team?  

Provide your information through the BambooHR form below.