Senior Regulatory Consultant
Cello Therapeutics, Inc. is a rapidly growing biotech company located in the Sorrento Valley—one of the major biotech hubs in the nation. Cello focuses on the development of novel nanotherapeutics based on biomimetic cell membrane-coated nanoparticles for cancer treatment. Cello offers a highly motivational and rewarding working environment with attractive salary and benefits.
The Senior Regulatory Consultant will be a key leader of our teams and will provide management and leadership for Regulatory Affairs to support the development and implementation of regulatory strategies and processes associated with cancer treatment products. This includes formulating and implementing CMC regulatory strategies for the development of novel nanomedicines for cancer treatment, provide guidance for CMC regulatory activities in line with US or ICH requirements, and working with partners to facilitate co-development and approvals. The Senior Regulatory Consultant will work closely with many different teams (i.e. R&D, Product Development, CMC, Quality, etc.) to ensure cohesion of regulatory strategy, regulatory requirements, and timely, compliant submission and approval of regulatory filings. Primary duties include:
- Serve as a liaison between regulatory authorities and the company to ensure that all projects have clearly defined regulatory paths and milestones leading to successful filings and approvals.
- Provide CMC Regulatory Affairs leadership within Regulatory Affairs and on cross-functional teams
- Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations
- Provide strategy and guidance to product teams addressing the regulatory requirements for both quality submissions and for manufacturing inspection requirements for CMC controls
- Provide direction and interpretation of regulatory requirements, regulatory intelligence, and benchmarking information.
- Help maintain forecasted timelines in support of overall programs.
- Facilitate timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD, BLA, MAA, NDA and their respective amendments/supplements.
- Facilitate timely regulatory approvals of new drugs.
- Provide oversight to cross-functional teams to ensure appropriate resource alignment to deliver on project milestones across company programs
- Develop and maintain working relationships internally and with partner organizations
- Provide insight into specific regulatory issues within the context of ongoing and future company programs.
- Proactively conduct background research needed and to propose effective and creative solutions.
- Maintain relationships with investigators and identify/interact with key opinion leaders
Desired Education, Skills, and Experience
- Extensive oncology experience—as oncologist and/or as oncology regulatory strategist
- Experience in oncology clinical trial design and oncology drug regulation
- Ability to identify key opinion leaders in field of oncology
- 10+ years of regulatory experience related to pharmaceutical development and commercialization, including significant strategic experience in CMC regulatory affairs
- S./ M.S./ Pharm.D/ Ph.D degree in life sciences or pharmaceutical-related field.
- RAC accreditation is desirable.
- Experience in representing sponsor and interfacing with the FDA and other regulatory bodies
- Demonstration of leadership in regulatory strategy and experience in regulatory interaction.
- Demonstrated track record of successful submissions of INDs, NDAs, BLA, and/or PMAs
- Experience in cGMP of oncology drugs.
- Extensive knowledge of US FDA/EMA drug development process, regulations and guidelines, including GMP and GCP, especially as it pertains to the development of oncology drugs.
- Good understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP and GLP requirements and SOPs
- Excellent conceptual, strategic, analytical, problem solving, and organizational skills.
- Excellent verbal and written communication skills
- Ability to operate proactively and independently.
Successful candidate must be authorized to work in the United States.
Cello Therapeutics, Inc. is an equal opportunity employer.