For The Candidates

Ra Mgr Subs management in Ops group - Regulatory Affairs - Biologics/Pharm
MD
Type: Full-Time
Category: Regulatory Affairs
Job ID: 847
Opportunity Description:
(301) Area Code                                                                                        D.C Area
 
 

Submission Coordinator/Manager

Position Description:

Responsible for developing and managing the regulatory document planning process and timelines for

major submissions, as well as ensuring that the deliverables meet applicable internal and international

regulatory requirements. Also responsible for supporting the expanded use of a corporate-wide

Electronic Document Management System, which will enable the company to transition from legacy and

paper submissions to electronic submissions for all projects.

Duties and Responsibilities:

1. Develop detailed multi-discipline project timelines and manage submission preparation from

planning to dispatch

2. Represent Reg Ops on project teams, driving timelines and deliverables related to submission

documents

3. Identify potential risks to the submission timelines or eCTD strategies (including life-cycle) and

develop risk mitigation strategies with input from key stakeholders and management

4. Collaborate with other departments to obtain missing information and correct erroneous information

that is intended for submission

5. Function as the in-house expert and resource for other departments regarding the submission content

templates, regulatory technology and electronic document management system; conduct high-level

formatting support as needed

6. Conduct initial review of submission components to ensure consistency with the Style Guide and

eCTD requirements

7. Perform various tasks to support global use of the EDMS (including migration of legacy documents

into the EDMS, which may include breaking apart some key submissions into its granular sections)

8. Cross-train on publishing software and related processes to provide back-up publishing support as

needed

9. Develop Regulatory Operations SOPs and WPDs governing eCTD submissions with input from

stakeholders and promote use of document policies and standards to create submission-ready

documents; responsible for coordination, implementation and ongoing improvement of these

processes

10. Develop training materials and provide training to internal and external personnel where appropriate

Requirements/Qualifications:

· Bachelor’s degree in life sciences, business administration or information technology, or equivalent

· Minimum of 5 years of biotech/pharmaceutical experience with responsibilities in submission

planning and project management, specifically hands-on experience planning, reviewing, and/or

compiling eCTD submissions across the lifecycle of the application

· Proven expertise using submission content templates, and electronic document management systems

for submission preparation and lifecycle management; experience with submission publishing

preferable

· Superior expertise with MS Word and other commonly used computer applications, including but

not limited to MS Project

· Knowledgeable of US and international regulations and guidances related to submission content and

format

· Detail-oriented with ability to work independently and on a team

· Excellent organizational skills with the ability to multi-task on several projects

· Highly flexible, adaptable and experienced in a fast-paced environment

 
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