Regulatory Affairs Program Manager

Avetix Engineering; New Jersey; On-site; USD 120,000 - 180,000; Full time

Job summary

The company, a publicly traded biopharmaceutical leader, seeks a Regulatory Affairs Program Manager to drive multi-regional regulatory programs from strategy to execution. You will coordinate with R&D, Clinical, Quality, Manufacturing, and Commercial to align timelines and risk mitigation, while translating global regulatory changes into clear action plans.

Ideal candidates will have 5+ years in regulatory affairs, 3+ years in multi-regional programs, and strong cross-functional collaboration

Qualifications

• Bachelor's degree in sciences, business, or project management required.
• 5+ years progressive experience in regulatory affairs or related field.
• 3+ years managing multi-regional regulatory programs (preferred).
• Strong cross-functional collaboration and on-schedule delivery.

Responsibilities

• Lead cross-functional regulatory programs from strategy through execution and set timelines, milestones, and risk-mitigation plans.
• Act as the regulatory point of contact across R&D, Clinical, Quality, Manufacturing, and Commercial.
• Track regulatory intelligence and translate changing global requirements into actionable strategy.
• Own SOPs and report program status to senior leadership.

Skills

Cross-functional collaboration

Project management

Strategic thinking

Education

Bachelor's degree in sciences, business, or project management

Job description

A publicly traded, commercial-stage biopharmaceutical company is developing next-generation immunotherapies designed to harness the body's own immune system against cancer and infectious disease. Their lead product - an FDA Breakthrough Therapy for non-muscle invasive bladder cancer - is already changing outcomes for patients. They're now looking for a Regulatory Affairs Program Manager to help drive the next wave of approvals.

What you'll do:

• Lead cross-functional regulatory programs from strategy through execution — setting timelines, milestones, and risk-mitigation plans
• Act as the regulatory point of contact across R&D, Clinical, Quality, Manufacturing, and Commercial
• Track regulatory intelligence and translate changing global requirements into clear, actionable strategy
• Own SOPs and process standardization, and report program status to senior leadership

What you'll bring:

• Bachelor's degree in sciences, business, or project management, with 5+ years of progressive experience
• 4+ years in regulatory affairs within pharma, biologics, or medical devices (preferred)
• 3+ years managing complex, multi-regional regulatory programs (preferred)
• Strong cross-functional collaboration skills and a track record of delivering on schedule

This is a chance to join a publicly traded biopharma company at a pivotal growth stage - working at the intersection of science, strategy, and execution to bring transformative therapies to patients faster.