Regulatory Submission Project Management Specialist

System One; Village of Tarrytown (NY); Remote; Part time

Job summary

A leading company is seeking a Regulatory Submission Project Management Specialist to coordinate and manage regulatory submissions remotely. The ideal candidate will have knowledge of regulatory processes and document management, alongside a Bachelor's Degree. You'll play a critical role in ensuring compliance and efficient operation within the Regulatory Submission Management group.

Benefits

Health and welfare benefits options

401(k) participation

Qualifications

• Requires a Bachelor's Degree and up to 2 years of experience.
• Strong knowledge of Regulatory Agency regulations.
• Expertise in document management and submission processes.

Responsibilities

• Manage routine regulatory submissions and track performance.
• Coordinate with Regulatory Operations on submission deliverables.
• Ensure completeness of scheduled submissions.

Skills

Knowledge of FDA regulations

eCTD knowledge

Document management expertise

Strong organizational skills

Software proficiency (VEEVA vault, MS Office)

Education

Bachelor's Degree

Tools

VEEVA Vault

MS Office

Adobe Acrobat

eDMS

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