Regulatory Submission Project Management Specialist

System One; Village of Tarrytown (NY); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company is seeking a Regulatory Submission Project Management Specialist for a remote, 9-month contract. The role involves managing routine regulatory submissions and requires knowledge of FDA and EMA regulations. Candidates should hold a Bachelor's Degree and have experience in submission processes.

Benefits

Health and welfare benefits

Medical, dental, vision coverage options

Participation in a 401(k) plan

Qualifications

• 0-2 years of industry and/or relevant experience is preferred.
• Ability to work with firm deadlines and adapt quickly.
• Strong knowledge of FDA, EMA, and ICH guidelines.

Responsibilities

• Manages and schedules routine regulatory submissions.
• Coordinates and tracks submissions for IND safety reports.
• Ensures overall completeness of scheduled submissions.

Skills

Regulatory Agency regulations knowledge

eCTD knowledge

Submission processes and systems experience

Document management expertise

VEEVA Vault knowledge

MS Office applications proficiency

Adobe Acrobat experience

eDMS proficiency

Education

Bachelor’s Degree

Job description

Job Title: Regulatory Submission Project Management Specialist
Location: 100% remote
Type: Contract (9-month renewable)
Compensation: $30-36/hour (dependent on experience)


Overview:
Provide support to the Regulatory Submission Management (Reg SM) group by working on routine regulatory submissions, responsible for tracking deadlines for various regulatory obligations, and assist with submission work for major submissions such as INDs, CTAs, BLAs and supplements, MAAs and variations.

A typical day might include the following:
· Schedules and manages routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces
· Provides support for monitoring and tracking performance of submission process for clinical site documentation (Form FDA 1572)
· Coordinates publications (literature references) for submissions across all programs
· Tracks submission deliverables for routine submissions, and provides support in tracking deliverables for larger submissions
· Manages overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status

This role may be for you if have:
· Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
· eCTD knowledge.
· Experienced in submission processes and systems
· Ability to work with firm deadlines and adapt quickly to changing priorities
· Expertise in document management
· Strong knowledge with VEEVA Vault, MS Office applications, Adobe Acrobat, electronic document management systems (eDMS) required.

To be considered for this role, you must have a Bachelor’s Degree and 0-2 years of industry and/or relevant experience



System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


Ref: #568-Clinical