Senior Regulatory Strategy Leader

Opus Regulatory Inc.; United States; On-site; USD 170,000 - 260,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan

Paid time off: 20 vacation days, 5_sic

Job summary

Opus Regulatory Inc. seeks a Principal Consultant, Regulatory Strategy to drive high-impact regulatory programs for biopharma clients. You will craft risk-informed strategies, lead health authority interactions, and guide cross-functional teams through development timelines and regulatory submissions.

The role requires extensive regulatory expertise, strong client leadership, and a track record of successful FDA interactions across multiple stages and therapeutic areas.

Qualifications

• Bachelor’s degree in a scientific, technical, or related discipline.
• Minimum of 15 years of progressive Regulatory Affairs experience, including 10 years in regulatory strategy.
• Experience leading complex regulatory development programs.
• Direct experience interacting with FDA and leading health authority meetings and major submissions.
• Experience in more than one therapeutic area and development stage.

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.
• Proactively identify regulatory issues and development risks and recommend mitigation strategies.
• Lead regulatory planning and execution across the product lifecycle, including timelines and submission coordination.
• Author, review, and oversee regulatory documents such as meetings packages, INDs, NDAs, BLAs, MAAs, DSURs, and supplements.
• Lead preparation for and participation in meetings with FDA, EMA, and other health authorities.
• Collaborate with cross-functional teams to respond to health authority questions.
• Represent Regulatory Affairs on development teams and advise stakeholders on regulatory implications.
• Monitor evolving regulatory guidance and translate into recommendations for clients.
• Build trusted client relationships and identify opportunities for additional support.

Skills

Regulatory strategy leadership

Cross-functional leadership

Health authority liaison

FDA interactions

Strategic advisory

Education

Bachelor’s degree in science/technical discipline

Advanced degree preferred

Job description

Opus Regulatory Inc. seeks a Principal Consultant, Regulatory Strategy to drive high-impact regulatory programs for biopharma clients. You will craft risk-informed strategies, lead health authority interactions, and guide cross-functional teams through development timelines and regulatory submissions.

The role requires extensive regulatory expertise, strong client leadership, and a track record of successful FDA interactions across multiple stages and therapeutic areas.