Ophirex, Inc. · 10 hours ago

Chief Regulatory Officer

California, United States

Full-time

Remote

Director/Executive

15+ years exp

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BiotechnologyMedical

Hiring Manager

Ellen Douglas

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Responsibilities

Collaborate closely with the executive team to execute the overall regulatory strategy

Ensure that all development activities comply with global regulatory requirements, in particular with FDA, CDSCO (India) and other relevant authorities.

Oversee the preparation of regulatory submissions, including INDs, CTAs and NDAs, ensuring high-quality documentation and timely approvals. Also experience negotiation final labels is a must.

Team Leadership and Development:

Build, mentor, and lead a high-performing regulatory team, fostering a culture of collaboration, innovation, and continuous improvement.

Provide ongoing professional development and career growth opportunities for team members.

Qualification

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Regulatory OperationsRegulatory SubmissionsBiotechnology ExpertiseFDA EngagementDrug DevelopmentAdvanced DegreeBusiness AcumenStrategic ThinkingCollaboration Skills

Required

Advanced degree in life sciences, biotechnology, or a related field (Ph.D., Pharm.D., M.D. preferred) and a business degree (MBA) with 15+ years of experience in the biotech or pharmaceutical industry.

Proven track record of successfully leading regulatory operations and regulatory submissions.

Expertise addressing complex scientific and regulatory issues, ensuring compliance with US and international regulations.

Exceptional communication and interpersonal skills, with the ability to effectively engage with internal teams and external partners (especially with a track record of engaging with FDA).

Strategic thinker with the ability to balance short-term execution with long-term planning.

Highly collaborative and capable of working in a fast-paced, dynamic environment.

Strong business acumen and understanding of the biotech industry landscape.

Passionate about advancing innovative therapies to improve patient outcomes.

Preferred

Other drug development experience desired (e.g. pre-clinical, clinical, CMC etc.) to round out capabilities.

Ideal candidate would have experience and understanding in regulatory domains such as Emergency Use Authorizations, Orphan Drug Status, Priority Review, Animal Rule and/or for rare diseases.