Regulatory Submissions Lead, Pharma (MLR)

Publicis Groupe; New York (NY); On-site; USD 54,000 - 80,000; Full time

Job summary

Publicis Groupe Holdings B.V. seeks a Senior Associate, Regulatory Operations to lead project-level preparation of promotional materials for MLR review in pharmaceutical client projects. You will track progress, advise on timelines, and coordinate with internal stakeholders to ensure timely submissions.

The role requires managing multiple projects, applying client and internal guidelines, and maintaining submission timelines while communicating effectively with teams and clients.

Qualifications

• Bachelor's degree required with 2–4 years of experience in the preparation of complex submission deliverables under tight deadline constraints.
• Proficient in Adobe Acrobat and Microsoft Office Suite.
• Clear communication and attention to detail.
• Top‑notch organizational skills.
• Clear, concise technical writing ability.
• Experience with Adobe InDesign and Photoshop preferred.

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

Adobe Acrobat

Microsoft Office

Communication

Attention to detail

Organizational skills

Technical writing

Education

Bachelor's degree

Tools

Adobe InDesign

Photoshop

Adobe Acrobat

Microsoft Office Suite

Job description

Publicis Groupe Holdings B.V. seeks a Senior Associate, Regulatory Operations to lead project-level preparation of promotional materials for MLR review in pharmaceutical client projects. You will track progress, advise on timelines, and coordinate with internal stakeholders to ensure timely submissions.

The role requires managing multiple projects, applying client and internal guidelines, and maintaining submission timelines while communicating effectively with teams and clients.