Head/ Sr Director of Global Regulatory Affairs
Location
Hayward, CA | United States
Job description
Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development. We have developed an innovative liquid biopsy technology that is empowering biopharma partners in clinical drug development and oncology medicine research. Our international business services provide molecular insights to the top 10 MNC BioPharma’s to support biomarker-driven clinical trials in US, EU, APAC including China. We believe our most important asset is our people and are dedicated to maintaining a thriving workplace. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication.
We invite people who share the same values to join us !
What you will get to do: This is a senior-level position responsible for overseeing and managing all aspects of global regulatory affairs activities for Invitro diagnostics (IVD) Class III (PMAs), and Companion Diagnostics (CDx).
Responsibilities - Responsible for setting strategy and leading the Predicine global regulatory affairs organization.
- Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities for In vitro diagnostics (IVD) Class III (PMAs), and Companion Diagnostics (CDx).
- Ensure submissions are accurate, complete, and in compliance with regulatory guidelines.
- Lead the development of regulatory strategies designed to maximize successful and expedient product registrations in worldwide jurisdictions.
- Direct submission of information to regulatory bodies, including the FDA, EMA, and other regulatory authorities across the globe.
- Ensure that regulatory submissions are complete, organized, of high quality, and compliant with applicable regional regulations.
- Interact directly with regulatory agencies; manage agency interactions.
- Conduct effective and timely regulatory intelligence and research.
- Provide risk assessments and recommendations for various regulatory scenarios.
- Represent the organization at regulatory and compliance meetings as both an expert and strategic business leader.
- Provide strategic and technical oversight to promote the compliance and quality of all products manufactured and distributed by Predicine.
- Monitor and interpret changes in regulations, guidelines, and legislation that may impact the company's products and operations. Stay up to date with current regulatory requirements and industry best practices.
- Participate in relevant conferences, seminars, and workshops.
- dentify and assess regulatory risks and propose appropriate mitigation strategies. Provide regulatory input to risk management activities, including risk assessments and risk mitigation plans.
- Review all relevant technical, business, regulatory information about existing or proposed products and advise on regulatory requirements/pathway which in turn drives project timelines and deliverables.
- Address internal or external quality complaints or compliance issues that may directly or indirectly risk the business.
- Provide detailed regulatory and quality guidance and input to the business development team.
- Review potential new business to determine how that work could fit in with ongoing regulatory projects.
- Represent the company in audits and in regulatory interactions with external agencies.
- Interact with Pharma partners on CDx projects
Qualifications - BS Degree in a life science or other relevant discipline.
- Advanced degree in life sciences (PhD preferred)
- Extensive experience (typically 10+ years)in the biotech or pharmaceutical industry, with direct IVD and CDx oversight.
- Demonstrates core values of integrity, respect, communication, quality, innovation, courage, caring and collaboration.
Annual base salary for this position could range from between $180,000 to $280,000 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. Compensation decisions are dependent on the facts and circumstances of each case. The successful candidate will also be eligible to participate in a performance-based bonus and stock allocation, various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and paid vacation.
We require all Predicine employees to be fully vaccinated and provide proof of vaccination on their first day of work. Predicine is proud to be an equal opportunity employer committed to hiring a diverse and inclusive workforce. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
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