What are the responsibilities and job description for the Head/ Sr Director of Regulatory Affairs position at Predicine?
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 regulatory affairs activities for Invitro diagnostics (IVD) Class III (PMAs), and Companion Diagnostics (CDx).
Responsibilities
Our Opportunity
Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-, urine- and tissue-based diagnostic assays for oncology.
What We Offer
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, for eligible employees and their dependents. Additionally. Other benefits include stock allocation and 401k benefits, and an employee referral program.
We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
The posted salary range is the estimated base salary range for this position. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data
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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 regulatory affairs activities for Invitro diagnostics (IVD) Class III (PMAs), and Companion Diagnostics (CDx).
Responsibilities
- Responsible for setting strategy and leading the Predicine 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.
- Identify 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
- 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.
Our Opportunity
Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-, urine- and tissue-based diagnostic assays for oncology.
What We Offer
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, for eligible employees and their dependents. Additionally. Other benefits include stock allocation and 401k benefits, and an employee referral program.
We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
The posted salary range is the estimated base salary range for this position. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data
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