Global Regulatory Strategy Leader

Physiol; Northern (KY); Hybrid; USD 150,000 - 230,000; Full time

Job summary

Physiol is seeking a senior Regulatory Affairs leader in the United States to guide global regulatory strategies and oversee filings, ensuring timely product approvals and ongoing compliance across the lifecycle.

The role partners with Marketing, Commercial, and Product Development to align claims and labeling with laws and company policies, while building strong relationships with regulators and external experts.

Qualifications

• Strategic regulatory leadership to cross-functional stakeholders.

Responsibilities

• Lead regulatory affairs teams and oversee the development, submission, and maintenance of global regulatory filings, including product registrations, supplements, amendments, progress reports, and periodic regulatory reports.
• Monitor and assess evolving regulatory requirements, guidance, and industry trends, proactively identifying and implementing necessary changes to internal policies, procedures, and compliance practices.
• Resolve complex regulatory issues by providing timely, risk-based recommendations and independently driving execution of solutions.
• Guide teams in developing global regulatory strategies and lead interactions with regulatory authorities to negotiate evidence requirements and facilitate product approvals.
• Ensure the timely approval and ongoing compliance of products throughout their lifecycle, minimizing regulatory risks and supporting business objectives.
• Provide strategic regulatory input to Marketing, Commercial, and Product Development teams regarding product claims, labeling, and promotional materials, ensuring compliance with applicable laws, regulations, and company policies.
• Build and maintain strong, collaborative relationships with key internal stakeholders, regulatory agencies, industry partners, and external experts.
• Demonstrate sound judgment, accountability, and a high level of professional competence while effectively managing multiple priorities in a dynamic environment.
• Serve as a role model and people leader by fostering a culture of integrity, accountability, collaboration, and continuous improvement while exemplifying BVI's core values.

Job description

Physiol is seeking a senior Regulatory Affairs leader in the United States to guide global regulatory strategies and oversee filings, ensuring timely product approvals and ongoing compliance across the lifecycle.

The role partners with Marketing, Commercial, and Product Development to align claims and labeling with laws and company policies, while building strong relationships with regulators and external experts.