Regulatory Submissions Lead - Pharma

Digitas Health; Philadelphia (Philadelphia County); On-site; USD 54,000 - 72,000; Full time

Job summary

Digitas Health in Philadelphia seeks a Senior Associate, Regulatory Operations to lead submission prep for Medical, Legal, and Regulatory review, coordinating with internal teams to meet client and internal guidelines.

You will manage timelines, assemble packages, balance multiple projects, and communicate status clearly while maintaining archives and supporting continuous process improvements. Strong Acrobat and MS Office skills, plus healthcare familiarity, are preferred.

Qualifications

• Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex submission deliverables under tight deadline constraints
• Clear communication and attention to detail
• Top notch organizational skills
• Clear, concise technical writing ability

Responsibilities

• Assemble submission packages through taking screenshots, annotating pertinent information, and attaching references and other ancillary documentation.
• Ensure components conform to both client and Digitas Health guidelines and requirements.
• Determine the time and effort required to create various components of each submission. Work directly with internal teams to develop submission timelines.
• Comfortably balance multiple projects simultaneously.
• Follow up with internal teams directly to communicate project status and timing expectations.
• Skillfully manage client expectations through clear and concise communication.
• Assist in maintaining departmental archive.

Skills

Clear communication

Attention to detail

Strong writing

Organizational skills

Education

Bachelor's degree

Tools

Adobe Acrobat

Microsoft Office Suite

Job description

Digitas Health in Philadelphia seeks a Senior Associate, Regulatory Operations to lead submission prep for Medical, Legal, and Regulatory review, coordinating with internal teams to meet client and internal guidelines.

You will manage timelines, assemble packages, balance multiple projects, and communicate status clearly while maintaining archives and supporting continuous process improvements. Strong Acrobat and MS Office skills, plus healthcare familiarity, are preferred.