Regulatory Affairs Consultant
San Diego, CA (Hybrid)
Company Overview:
Cullgen is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies designed to improve the lives of patients suffering from critical conditions such as pain, cancer and inflammation. Cullgen has created a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients. By leveraging its expertise in targeted protein degraders, Cullgen believes its product candidates have many distinct advantages over other therapeutic modalities, including higher selectivity, improved therapeutic profile and avoidance of known toxicities. Cullgen’s lead product candidate, CG001419, is an oral pan-tropomyosin receptor kinase (“TRK”) degrader that recently completed patient enrollment in a Phase 1 trial for the treatment of acute post-operative pain. The molecule is also being studied in a Phase 1 trial for the treatment of solid tumors. Cullgen’s second product candidate, CG009301, is a GSPT1 degrader being studied in a Phase 1 trial for the treatment of blood cancers, including relapsed/refractory acute myeloid leukemia (“AML”), higher-risk myelodysplastic syndrome and acute lymphoblastic leukemia. In addition to CG001419 and CG009301, Cullgen is also progressing a number of preclinical programs, including certain partnered programs, targeting indications within oncology and inflammatory diseases. For more information, please visit www.cullgen.com
Job Summary:
We’re looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. You will work collaboratively with other functional leaders across the organization, as well as external stakeholders. Our ideal candidate will have experience leading the regulatory function in different therapeutics areas and includes both tactical and strategic responsibilities.
Responsibilities:
Work with the team to compile submissions of original IND and responses to all regulatory authority queries.
Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc.), internal preparation and agency meetings.
Serve as a company contact with the FDA and other regulatory authorities.
Ensure all external data complies with required specifications, standards, protocols, SOPs and overall clinical objectives.
Enable creative solutions to regulatory challenges to timely advance therapeutics to meet key development milestones including positioning for successful pivotal trials and registration.
Requirements:
15+ years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required.
D., PharmD or other relevant post-graduate level training strongly preferred.
Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development.
Experience with Type D meetings and responses needed.
Ability to lead and advise under pressure, respond to complex operational challenges with innovative solutions supported by appropriate tactics.
Ability to occasionally work onsite from our San Diego offices.
This is part time consulting role, and expected to be 10 hours/week. Local candidates highly preferred.