Vp of finance Jobs in Clovis ca
Last updated: 9 hours ago
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- Promoted
Head of Regulatory (CRO, SVP or VP)
Ophirex, Inc.CA, United States- Promoted
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Sully.aiCA, California, United States, United StatesHead of Regulatory (CRO, SVP or VP)
Ophirex, Inc.CA, United States13 days ago
Job type
- Full-time
Job descriptionBuild, 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. 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. Other drug development experience desired (e.g. pre-clinical, clinical, CMC etc.) to round out capabilities Expertise addressing complex scientific and regulatory issues, ensuring compliance with US and international regulations 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 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.
Ophirex, Inc., is a Public Benefit Corporation focused on global health and currently is a virtual company. We are recruiting for a Head of Regulatory (CRO, SVP or VP) who will lead and oversee all aspects of regulatory, focusing on the advancement of development programs from preclinical stages through to commercialization. This role is critical for ensuring the seamless integration of development activities into regulatory dossiers, adherence to regulatory standards, timely execution of project milestones and achieving company’s goal of submitting it’s first NDA. The ideal candidate will bring deep expertise in biotech, and strong scientific and business acumen.
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 :
Qualifications :