Head Of Global Regulatory Affairs

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 !

Learn more about Predicine: https://online.flippingbook.com/view/403420724/

As the Head ofRegulatory Affairs, you are tasked to support Predicine’s oncology and infectious disease products and lead Global Regulatory strategy.

What you will get to do:

This is a senior-level position responsible for overseeing and managing all aspects of Regulatory Affairs activities. This role is critical for ensuring compliance with applicable regulations and guidelines set forth by regulatory authorities. You will provide regulatory advice and analysis, support documentation including company SOPs, legal contracts, product development documentation, planning, implementation, and maintenance of a robust QMS in compliance with applicable global regulations. Oversee company communication and cooperation with external regulatory agencies/auditors and drive strategy decisions.

Responsibilities:

• Regulatory Submissions: 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.
• Compliance and Regulatory Intelligence: 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. Provide advice and guidance on compliance issues and potential risks. Participate in relevant conferences, seminars, and workshops.
• Interactions with Regulatory Authorities: Serve as the primary point of contact for regulatory agencies. Represent the company in meetings, discussions, and negotiations with regulatory authorities. Prepare and present regulatory strategies, data, and responses to regulatory queries.
• Risk Assessment and Mitigation: 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

Qualifications, Education, Experience:

• BS Degree in a life science or other relevant discipline.
• Advanced degree in life sciences, PhD preferred.
• Extensive experience (typically 10+ years, 12+ years for senior director) in the biotech or pharmaceutical industry, with life science/ diagnostic/oncology industry experience.
• Proven strong problem-solving ability and root cause analysis skills
• Minimum 8+ years of direct experience with national and international regulatory registrations, submission, regulations, and developing effective relationships with regulatory agencies.

Learn more about Predicine: https://online.flippingbook.com/view/403420724/

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

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.