Senior Director, Regulatory Affairs

BioPhase; California (MO); On-site; USD 180,000 - 240,000; Full time

Job summary

BioPhase is seeking an experienced regulatory affairs leader to guide regulatory strategy and execution for clinical development programs. This role will partner with scientific, clinical, technical, and business stakeholders to support program planning, regulatory submissions, and interactions with health authorities.

The ideal candidate combines strategic thinking with a hands-on approach and can provide clear direction in a growing, fast-paced organization.

Qualifications

• Bachelor's degree in life sciences or related field is required; advanced degree preferred.
• Significant regulatory affairs experience in biotech/pharma, including leadership.
• Experience developing regulatory strategy and supporting clinical-stage programs.
• Hands-on experience with major regulatory submissions and health-authority interactions.
• Working knowledge of US and EU regulatory requirements.
• Strong written, verbal, organizational, and project-management skills.

Responsibilities

• Develop and maintain global regulatory strategies to support clinical development and program objectives.
• Lead planning, preparation, review, and coordination of regulatory submissions and related documentation.
• Serve as regulatory representative on cross-functional development teams.
• Provide regulatory guidance on development plans, study-related documents, and key program decisions.
• Prepare for and lead interactions with health authorities in the US and other markets.
• Monitor regulatory requirements and advise internal teams on impact.
• Identify regulatory risks and communicate issues to stakeholders.
• Work with internal teams and external partners to ensure regulatory activities are completed on schedule.
• Support ongoing development of regulatory processes and a collaborative team environment.

Skills

Regulatory leadership

Regulatory strategy

Health-authority interactions

Cross-functional collaboration

Regulatory submissions

Project management

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

We are seeking an experienced regulatory affairs leader to guide regulatory strategy and execution for clinical development programs. This position will partner with scientific, clinical, technical, and business stakeholders to support program planning, regulatory submissions, and interactions with health authorities. The ideal candidate combines strategic thinking with a hands-on approach and can provide clear direction in a growing, fast-paced organization.

Key Responsibilities

• Develop and maintain global regulatory strategies that support clinical development and broader program objectives.
• Lead the planning, preparation, review, and coordination of regulatory submissions and related documentation.
• Serve as the regulatory representative on cross-functional development teams.
• Provide regulatory guidance on development plans, study-related documents, and key program decisions.
• Prepare for and lead interactions with health authorities in the United States and other markets, as applicable.
• Monitor relevant regulatory requirements and advise internal teams on their potential impact.
• Identify regulatory risks, recommend practical solutions, and communicate issues to appropriate stakeholders.
• Work with internal teams and external partners to ensure regulatory activities are completed accurately and on schedule.
• Support the continued development of regulatory processes and contribute to a collaborative team environment.

Qualifications

• Bachelor's degree in life sciences or a related field; an advanced degree is preferred.
• Significant regulatory affairs experience in the biotechnology or pharmaceutical industry, including experience in a leadership capacity.
• Experience developing regulatory strategy and supporting clinical-stage programs.
• Hands-on experience with major regulatory submissions and health-authority interactions.
• Working knowledge of U.S. and EU regulatory requirements.
• Ability to evaluate complex information, exercise sound judgment, and provide practical recommendations.
• Demonstrated ability to influence and collaborate effectively across functions.
• Strong written, verbal, organizational, and project-management skills.