Global Regulatory Strategy Lead for Submissions & Intelligence

Socket.dev; New Jersey; On-site; USD 110,000 - 165,000; Full time

Job summary

Socket.dev in New Jersey seeks a Regulatory Affairs Lead to develop and implement regulatory strategies across multiple therapeutic areas. You will engage with FDA and global agencies, drive high-quality submissions such as INDs, NDAs, and ANDAs, and lead cross-functional teams to optimize product labeling and compliance.

The role requires 3–5 years of pharma regulatory experience, a life sciences degree, and strong leadership and communication skills.

Qualifications

• BS/BA in life sciences required.
• 3–5 years regulatory or related experience in pharmaceutical industry.
• Experience with IND and/or NDA/NDAs/ANDAs filings; regulatory intelligence experience preferred.

Responsibilities

• Develop and lead regulatory strategies independently for moderately to highly complex projects.
• Direct interaction with FDA and other agencies throughout development lifecycle.
• Lead preparation of high-quality regulatory submissions (INDs, NDAs, ANDAs, supplements).
• Maintain knowledge of global regulatory environment and coordinate intelligence activities.
• Summarize and communicate regulatory intelligence and its impact to teams.
• Establish response plans and ensure alignment across functions.

Skills

Leadership

Regulatory strategy

FDA liaison

Cross-functional teamwork

Regulatory intelligence

Education

BS/BA in life sciences

Masters/PhD or RAC preferred

Job description

Socket.dev in New Jersey seeks a Regulatory Affairs Lead to develop and implement regulatory strategies across multiple therapeutic areas. You will engage with FDA and global agencies, drive high-quality submissions such as INDs, NDAs, and ANDAs, and lead cross-functional teams to optimize product labeling and compliance.

The role requires 3–5 years of pharma regulatory experience, a life sciences degree, and strong leadership and communication skills.