Senior Regulatory Strategist

Join us in redefining what it means to work for a CRO.

When you work at Rho, it's more than just a job-you become part of the Rho Factor. We're a proud bunch of science nerds who love tackling big challenges together. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

Whether you're a data wizard, analytical genius, project mastermind, or any other role, you'll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work-and each other.

You'll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.

We are seeking a highly experienced and strategic global regulatory expert, to join Rho as Senior Regulatory Strategist. This role serves as the senior regulatory advisor, providing global strategic regulatory guidance to Rho clients and project teams in support of our clients' interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. The ideal candidate will provide comprehensive regulatory oversight and mentorship, and support business development efforts to expand Rho's global regulatory business.

Our Regulatory Strategy Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Key Responsibilities:

Senior Regulatory Advisor:

• Serve as the senior regulatory expert, providing strategic advice and guidance to multidisciplinary teams on product development, regulatory submissions, and regulatory considerations for global clinical conduct.
• Provide expert regulatory review for regulatory documents.

Strategic Oversight:

• Develop and implement comprehensive global regulatory strategies across drug, biologic, and device programs supporting clients from pre-CTA/IND through marketing applications and lifecycle management.
• Provide strategic oversight across global regulatory engagements (FDA, EMA, MHRA, Health Canada, and others), including expedited programs and complex regulatory pathways.
• Translate regulatory intelligence and trends into proactive, actionable guidance for internal teams and sponsor partners.

Submission Excellence

• Oversee the preparation, submission, and maintenance of global regulatory filings, ensuring accuracy and compliance with global regulations to meet regulatory and client expectations.
• Elevate quality and consistency across submission packages, leveraging Rho's process-driven and client-focused approach.

Cross-Functional Collaboration:

• Collaborate with service area leads to align regulatory strategy with clinical, data, and quality assurance that Rho delivers.

Mentorship and Training:

• Provide strategic oversight and mentorship to regulatory professionals within the organization, fostering their development and ensuring the team remains current with the latest regulatory trends and best practices.

Innovation and Operational Leadership

• Champion the adoption of advanced technologies, such as AI-enabled tools and regulatory technology platforms, to improve efficiency, accuracy, and insight.
• Strengthen internal systems, workflows, and SOPs to support scalable and sustainable regulatory operations.
• Foster a mindset of continuous improvement by incorporating metrics, feedback, and lessons learned.

Client Engagement & Business Growth

• Serve as the senior regulatory advisor in sponsor relationships establishing trust and driving strategic direction on regulatory matters across Rho's services.
• Partner with Business Development and Marketing to showcase Rho's regulatory capabilities in proposals, client interactions, and strategic planning discussions.
• Identify new service opportunities and tailor solutions to meet evolving client needs and industry trends across product types and global markets.

• PhD/PharmD (or equivalent demonstration of analytical ability) along with 20 years' experience in development programs that include inter-related clinical, clinical pharmacology, nonclinical, CMC, and regulatory affairs, with extensive experience in global regulatory strategy and submission execution, including direct agency interaction.
• Deep knowledge of global regulatory frameworks and a demonstrated ability to guide innovative or complex products through development.
• Experience with FDA, EMA, and Health Canada is required; experience with ROW regulatory authorities (meetings, submissions, strategy) desired.
• Strong strategic thinking, problem-solving, and decision-making skills.
• Excellent communication and interpersonal abilities.
• Demonstrated ability to mentor and train regulatory professionals, fostering a culture of continuous learning and development.
• Regulatory Affairs Certification (RAC) desired.

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.