Director, Regulatory Affairs

BLOSSOMHILL THERAPEUTICS INC•San Diego, CA

6d•$209,050 - $249,042•Onsite

About The Position

BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors. For more information visit BlossomHill Therapeutics [http://www.bhtherapeutics.com/]. BlossomHill Therapeutics is seeking a Director, Regulatory Affairs, reporting to the Executive Director, Regulatory Affairs, to work with cross-functional teams to develop worldwide regulatory strategies and execute submission activities to global Health Authorities for BlossomHill’s development programs. The successful applicant will serve as a Regulatory Program Lead for one or more programs in the clinical pipeline as well as work across all programs to support the development and commercialization of BlossomHill’s products globally. Additional responsibilities include involvement in the writing of regulatory submission documents, coordinating all aspects of paper and electronic regulatory submissions, and proactively monitoring the global regulatory landscape to provide relevant regulatory intelligence to the development teams. This is an onsite position based in BlossomHill's San Diego office.

Requirements

Bachelor’s degree in a scientific, healthcare, or related discipline; advanced degree (Master’s or PhD) preferred with approximately 8–10 years of relevant regulatory experience in the pharmaceutical, biotechnology
Excellent understanding of, and ability to interpret, global regulations, policies, and guidelines (FDA, EMA, PMDA, etc.)
Experience in proactively identifying and mitigating issues in various aspects of the drug development process.
Experience with development of regulatory strategy documents and contributing to clinical development plans.
Experience with regulatory filings, including electronic submissions, e.g., INDs, CTAs, annual reports, safety reporting, etc.
Knowledge and experience in the Regulatory aspects of biomarkers, CTAs, companion diagnostics, and familiarity with IDE, PMD and IVD requirements is a plus.
Experience in oncology therapeutic areas (solid tumor and/or hematologic malignancies) strongly preferred. Specific experience in lung cancer would be an advantage.
Excellent organizational and project management skills, with a proven track record of planning, prioritizing, and delivering multiple concurrent writing projects to high standards and tight timelines.
Ability to work effectively in a team environment, with excellent interpersonal and communication skills to collaborate across levels and functions and with CROs and external consultants.
Strong technical skills with common software tools (eg, word processing, spreadsheets, document management systems, and online research), including submission‑ready formatting and familiarity with electronic document workflows.
Ability to think strategically about document purpose, audience, and messaging, while executing hands‑on writing and driving timelines to completion.

Nice To Haves

Advanced degree (Master’s or PhD) preferred
Knowledge and experience in the Regulatory aspects of biomarkers, CTAs, companion diagnostics, and familiarity with IDE, PMD and IVD requirements is a plus.
Experience in oncology therapeutic areas (solid tumor and/or hematologic malignancies) strongly preferred. Specific experience in lung cancer would be an advantage.

Responsibilities

Support the development of innovative US and global regulatory strategies for the assigned program(s), and the planning, preparation (including authoring where relevant) and execution of regulatory submissions throughout the product life cycle. This will include Requests and Briefing Documents for Health Authority meetings, Clinical Trial Applications (CTAs, INDs), Pediatric Plans, Orphan Designations, Expedited Pathway Applications (Breakthrough, PRIME), and Marketing Applications (NDAs, MAAs).
Lead the creation of timely, high-quality responses to all Health Authority questions for the assigned program(s).
Develop and maintain detailed Regulatory Strategy Documents/Project Plans, and regulatory components of the Target Product Profile.
Provide regulatory guidance and education through interpretation of regulations, policies, and guidelines, to drive efficient clinical development and continued regulatory compliance.
Maintain regulatory files in a format consistent with internal requirements.
Provide technical regulatory review and expertise for the creation and maintenance of internal SOPs, policies and guidance documents to ensure regulatory compliance.
Partner with cross-functional subject matter experts to organize and prepare documents for regulatory health authority submissions, contributing to document strategy, structure, and key messages while aligning with overall program plans set by the Executive Director.
Represent Regulatory Affairs on project and study teams for assigned programs, advising teams on regulatory requirements for key documents.
Collaborate effectively with Research & Development colleagues, including clinical research, regulatory, safety, biostatistics, clinical operations, translational medicine, and discovery, to ensure alignment and accuracy of clinical and regulatory content.
Provide input to the Executive Director, Regulatory Affairs on strategy development, operational improvements, tools, and processes to enhance efficiency and quality of deliverables.