US Regulatory Lead

Meet Life Sciences; United States; Remote; USD 80,000 - 115,000; Full time

Job summary

A leading life sciences company is seeking a Regulatory Affairs Manager focused on oncology. This fully remote position requires 6-10 years of regulatory experience, particularly with FDA submissions. The role involves managing submissions, supporting teams, and ensuring compliance with regulations.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 6–10+ years of regulatory affairs experience in the pharmaceutical/biotech industry.
• Familiarity with IND, NDA, and BLA submissions.
• Strong knowledge of FDA regulations and submission processes.

Responsibilities

• Manage IND/NDA/BLA submissions and lifecycle activities.
• Support cross-functional teams as the US Regulatory representative.
• Assist in preparing for FDA meetings and regulatory presentations.

Skills

Knowledge of FDA regulations

Regulatory submissions

Regulatory intelligence

Education

Bachelor’s degree in a scientific discipline

Advanced degree

Tools

eCTD format

CDER NextGen Portal

Job description

Direct message the job poster from Meet Life Sciences

Regulatory Affairs Manager – Remote (Oncology Focus)

Summary:

Seeking a Regulatory Affairs Manager with 6–10+ years of experience to support regulatory submissions and maintenance activities for oncology products. This fully remote role is ideal for professionals with strong knowledge of FDA regulations and experience with IND, NDA, and BLA submissions.

Key Responsibilities:

• Manage IND/NDA/BLA submissions and lifecycle activities (e.g., annual reports, DSURs, PADERs, PSURs, lot distribution reports).
• Support cross-functional teams as the US Regulatory representative.
• Assist in preparing for FDA meetings, regulatory intelligence gathering, and creation of regulatory presentations.
• Maintain and track US regulatory deliverables in internal systems.
• Coordinate and draft process documentation for regulatory submission types.

Qualifications:

• Bachelor’s degree in a scientific discipline; advanced degree a plus.
• 6–10+ years of regulatory affairs experience in the pharmaceutical/biotech industry.
• Strong knowledge of FDA regulations and submission processes (IND/NDA/BLA).
• Familiarity with eCTD format and CDER NextGen Portal preferred.

Location & Travel:

• Fully remote

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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