Senior Regulatory Consultant Job at 5945 Pacific Center Blvd., San Diego, CA

ZjY4L1BkQUhFUXVhd0oreHBTN1AvQXllMlE9PQ==
  • 5945 Pacific Center Blvd.
  • San Diego, CA

Job Description

Senior Regulatory Consultant

Part-Time
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.

Position Summary

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.

Job Tags

Part time,

Similar Jobs

Area Temps, Inc.

Senior Title & Escrow Officer Job at Area Temps, Inc.

01 - 176711 nw Join Our Team as a Senior Title & Escrow Officer - Lorain, Ohio Schedule: Monday through Friday 8:30 a.m. to 5 p.m. Are you a seasoned real estate professional with a passion for precision and a deep understanding of Ohio real estate law? We're looking...

Image Specialty Partners

Practice Manager - Pediatric Dental Office Job at Image Specialty Partners

 ...Bay Area Kids Dentistry in San Jose, CA is a leading pediatric dental practice dedicated to providing exceptional dental care in a fun,...  ...of oral healthcare. We are looking for a dedicated Practice Manager to lead our team, ensure operational excellence, and drive practice... 

Mead & Hunt

Hydrology & Hydraulics Engineer Job at Mead & Hunt

 ...in civil engineering or related engineering field from an accredited college or university At least two (2) years of relevant hydrology & hydraulics experience The ideal candidate will have experience with any/all of the following: HEC-HMS, HEC-RAS (including... 

FAENA

Housekeeping Manager Job at FAENA

 ...Faena the ultimate destination for the sophisticated traveler to New York. Job Description JOB OVERVIEW The Housekeeping Manager oversees the day-to-day operations of the housekeeping department, ensuring cleanliness, order, and presentation standards across... 

ProPivotal Staffing

Mostly Remote - RN Safety & Quality Reviewer Job at ProPivotal Staffing

 ...Mostly Remote - RN Safety & Quality Reviewer The Quality Reviewer - OASIS & ICD-10 Coding ensures compliance and accuracy in OASIS documentation and ICD-10 coding for home health and hospice services. This role supports quality assurance, conducts audits, and trains...