Senior Regulatory Strategy Consultant

Opus-Regulatory; Miami (FL); On-site; USD 170,000 - 250,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life Insurance

401(k) plan

Job summary

Opus Regulatory in the United States seeks a Principal Consultant, Regulatory Strategy to lead risk-informed regulatory plans across product lifecycles and to drive strategic interactions with health authorities like the FDA and EMA. You will mentor teams, develop timelines, and deliver high-impact regulatory guidance for diverse biotech and pharma clients.

The role requires 15+ years in Regulatory Affairs with a focus on strategy and strong client-facing leadership.

Qualifications

• Bachelor’s degree in a scientific, technical, or related discipline.
• Minimum 15 years of progressive Regulatory Affairs experience, including at least 10 years in regulatory strategy.
• Experience interacting with FDA and leading health authority meetings and major regulatory submissions.
• Experience in more than one therapeutic area and development stage.
• Strong knowledge of US and ICH regulatory requirements and ability to apply them strategically and operationally.
• Excellent client-facing communication, leadership, and relationship-management skills.

Responsibilities

• Serve as a senior Regulatory Affairs advisor to client teams, providing tailored guidance on development pathways, regulatory requirements, health authority interactions, submissions, and industry best practices.
• Develop and implement risk-informed regulatory strategies aligned with client objectives and program risks.
• Lead regulatory planning and execution across the product lifecycle, including timelines and submissions.
• Author, review, and oversee regulatory documents and health authority interaction packages.
• Lead preparation for meetings with FDA, EMA, and other health authorities, as applicable.
• Mentor and support other Opus consultants and contribute to internal knowledge sharing.

Skills

Client-facing communication

Leadership

Relationship management

Regulatory strategy

Cross-functional collaboration

FDA interactions

Education

Bachelor’s degree in a scientific field

Job description

Opus Regulatory in the United States seeks a Principal Consultant, Regulatory Strategy to lead risk-informed regulatory plans across product lifecycles and to drive strategic interactions with health authorities like the FDA and EMA. You will mentor teams, develop timelines, and deliver high-impact regulatory guidance for diverse biotech and pharma clients.

The role requires 15+ years in Regulatory Affairs with a focus on strategy and strong client-facing leadership.