Senior Manager Regulatory Affairs

Barrington James; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

A leading biotech company in the United States is seeking a Senior Manager of Regulatory Affairs to lead global regulatory strategies and submissions. The ideal candidate will have over 5 years of experience in Regulatory Affairs, particularly within the biotech/pharma sector. This is a full-time role that offers the opportunity to engage directly with global health authorities and contribute to innovative therapies for cardiovascular health.

Qualifications

• 5+ years in Regulatory Affairs (biotech/pharma), preferably with cardiovascular/metabolic experience.
• Strong track record in INDs/CTAs and global submissions.
• Experience engaging with FDA/EMA.

Responsibilities

• Develop and execute regulatory strategies from IND/CTA to NDA/BLA.
• Lead regulatory submissions and health authority interactions.
• Advise teams on clinical plans and expedited pathways.

Skills

Regulatory Affairs expertise

Cross-functional collaboration

Strategic planning

Adaptability

Education

Advanced degree (MSc, PhD, PharmD, MD)

Job description

Overview

Join a fast-growing biotech developing innovative therapies for cardiovascular and metabolic diseases. Backed by strong investment and a leadership team with proven success, the company is advancing a pipeline of life-changing treatments to address major unmet needs in heart health and metabolism.

The Role

We’re seeking a Senior Manager of Regulatory Affairs to lead global regulatory strategy and submissions across our pipeline. You’ll work cross-functionally and engage directly with global health authorities to drive programs from early development to approval.

Key Responsibilities

• Develop and execute regulatory strategies from IND/CTA to NDA/BLA.
• Lead regulatory submissions and health authority interactions (FDA, EMA, etc.).
• Advise teams on clinical plans, endpoints, and expedited pathways.
• Collaborate across R&D, CMC, Clinical, and Commercial.
• Support regulatory intelligence and mentor junior team members.

You Bring

• 5+ years in Regulatory Affairs (biotech/pharma), with cardiovascular/metabolic experience preferred.
• Strong track record in INDs/CTAs and global submissions.
• Experience engaging FDA/EMA and navigating complex regulatory environments.
• Advanced degree preferred (MSc, PhD, PharmD, MD).
• Strategic, adaptable, and collaborative mindset.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Science

Industries

• Research Services and Biotechnology Research