Senior Regulatory Strategy Lead for Biotech & Pharma

PLG; United States; On-site; USD 120,000 - 210,000; Full time

Job summary

ProductLife Group seeks a Senior Regulatory Affairs Consultant to lead regulatory engagements across biotechnology and pharmaceutical programs. The role spans from pre-IND through registration, shaping regulatory strategies and submission plans in collaboration with Clinical, CMC, and Quality teams.

The ideal candidate has 10–12 years in Regulatory Affairs, with experience in FDA interactions and global guidance, and a strong track record of delivering complex regulatory submissions.

Qualifications

• Develop and execute regulatory strategies for development programs.
• Coordinate multiple regulatory workstreams and submissions.
• Lead interactions with Health Authorities (FDA and others).
• Draft, review, and manage regulatory documents and briefs.
• Guide budgets, timelines and resource planning for programs.

Responsibilities

• Lead regulatory projects from early development through approval.
• Prepare and manage Health Authority meeting packages and responses.
• Coordinate cross-functional teams (Clinical, CMC, Quality, Regulatory Operations).
• Support business development with regulatory capabilities and proposals.

Skills

Regulatory strategy

Regulatory leadership

Cross-function collaboration

Project management

FDA interactions

Education

Bachelor's degree in life sciences

Advanced degree / regulatory cert (preferred)

Job description

ProductLife Group seeks a Senior Regulatory Affairs Consultant to lead regulatory engagements across biotechnology and pharmaceutical programs. The role spans from pre-IND through registration, shaping regulatory strategies and submission plans in collaboration with Clinical, CMC, and Quality teams.

The ideal candidate has 10–12 years in Regulatory Affairs, with experience in FDA interactions and global guidance, and a strong track record of delivering complex regulatory submissions.