Regulatory Writing Manager — Submissions & Strategy

Socket.dev; Germantown (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Socket.dev in Germantown, MD, is seeking a Manager, Regulatory Writing to guide regulatory messaging strategy and oversee writing for assigned programs to support submissions and business objectives.

You will collaborate cross-functionally, author and review IND/CTA and CTD/BLA documentation for eCTD submissions, manage external writers, QC documents, and drive timelines to ensure quality and compliance.

Qualifications

• Bachelor’s degree in life sciences or relevant field.
• 4+ years of experience in regulatory affairs writing in the Biotech/Pharmaceutical industry.
• Strong understanding of global regulatory requirements.

Responsibilities

• Independently manage regulatory writing activities across assigned programs.
• Author or oversee regulatory submission documents including IND/CTA supporting documents and CTD/BLA/MAA documentation for eCTD submissions.
• Comply with internal and external processes while managing the writing review process to ensure timely completion and quality of documents.
• Lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications.
• Coordinate external writers to ensure messaging consistency and timely delivery of documents per project plans.
• Perform QC review of documents for submissions (typographical, grammatical, formatting, clarity).
• Generate document timelines.
• Other duties as assigned.

Skills

Regulatory writing

Cross-functional collaboration

Written communication

Time management

Attention to detail

Risk mitigation

Education

Bachelor's degree in life sciences

Job description

Socket.dev in Germantown, MD, is seeking a Manager, Regulatory Writing to guide regulatory messaging strategy and oversee writing for assigned programs to support submissions and business objectives.

You will collaborate cross-functionally, author and review IND/CTA and CTD/BLA documentation for eCTD submissions, manage external writers, QC documents, and drive timelines to ensure quality and compliance.