Regulatory Affairs Consultant in Medtech/IVD, supporting clients through product lifecycle. Involved in regulatory strategies, submissions, and compliance with EU and FDA regulations.
About the role
- Senior Director/Vice President of Regulatory Affairs at biopharmaceutical company Korro. Overseeing regulatory strategies for clinical development and commercial pipelines with global health authorities.
Responsibilities
- Serve as the strategic and operational leader responsible for developing and executing global regulatory strategies to support clinical development, registration, and commercialization of the company’s pipeline
- Provide leadership and direction to internal teams and external partners, ensuring regulatory compliance and fostering effective interactions with global health authorities
- Report to the Chief Scientific Officer and work in close partnership with the VP of Clinical Operations, VP of Clinical Development, and VP Research & Preclinical
- Develop and implement global regulatory strategies aligned with corporate objectives for preclinical, clinical, and commercial programs
- Lead preparation and submission of INDs/CTAs, BLAs/NDAs/MAAs, and other key filings
- Anticipate and mitigate regulatory risks; provide proactive guidance on evolving regulatory landscapes
- Oversee all regulatory submissions, ensuring completeness, accuracy, and compliance with applicable regulations
- Manage regulatory documentation systems and ensure inspection readiness
- Lead interactions with external consultants, CROs, and regulatory agencies
- Partner closely with Clinical Development, CMC, Nonclinical, and project teams to align regulatory strategies with development plans
- Serve as a trusted advisor to senior leadership on regulatory implications of corporate decisions
Requirements
- Advanced degree (PharmD, PhD, MD, or MS) in life sciences or related field
- 12+ years of progressive regulatory affairs experience in the biopharmaceutical industry, including leadership of regulatory strategy and submissions
- Successful track record of interactions with FDA and global agencies, and experience leading major submissions (INDs, NDAs, BLAs, MAAs)
- Experience across multiple phases of development (preclinical through post-approval) strongly preferred
- Deep understanding of global regulatory frameworks and guidelines
- Proven ability to lead cross-functional initiatives and manage complex regulatory programs
- Strong communication and interpersonal skills, with executive presence
- Ability to thrive in a fast-paced, dynamic, and science-driven environment
- Strategic thinker with operational excellence
- High integrity and credibility with regulators and internal stakeholders
- Collaborative leadership style with strong influencing skills
- Entrepreneurial mindset and comfort operating in an emerging biotech setting
Benefits
- Korro offers competitive compensation, including equity-based compensation
- Comprehensive benefits package
- Medical, dental, vision insurance
- 401(k) retirement plan
- Life insurance
- Dependent care flexible spending account
- Company-funded health savings account
- Free parking
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