Regulatory Affairs Manager

Company Overview

ORIC Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies that overcome resistance in cancer treatments. Their pipeline includes ORIC-944, an allosteric inhibitor targeting the PRC2 complex in prostate cancer, and ORIC-114, a brain-penetrant inhibitor designed for cancers harboring specific EGFR and HER2 exon 20 mutations. The company operates out of offices in South San Francisco and San Diego, California.

Role Overview

The Regulatory Affairs Manager will play a crucial role in advancing ORIC's oncology products through clinical development stages. The successful candidate will work collaboratively across various teams including regulatory operations, quality, CMC, nonclinical, and clinical to support efficient and compliant regulatory submissions. This role requires balancing strategic planning with meticulous execution and clear communication within a cross-functional environment.

Key Responsibilities

• Assist in regulatory submissions and contribute to strategic regulatory planning for assigned programs.
• Prepare and deliver submissions that meet regulatory requirements timely and accurately.
• Coordinate the creation, assembly, review, and filing of complex regulatory documents, involving collaboration with internal teams and CRO partners.
• Manage and monitor regulatory submission timelines effectively.
• Collaborate cross-functionally to ensure compliance and alignment across departments.
• Maintain standards for submission accuracy, completeness, and consistency; archive regulatory correspondence appropriately.
• Review investigator packages and support site initiation from a regulatory standpoint.
• Stay informed on current regulatory developments, guidance, and initiatives, communicating insights internally.
• Support development and review of SOPs to maintain regulatory compliance.
• Uphold company values and comply with policies and regulatory standards in all responsibilities.

Qualifications

• Bachelor’s degree in scientific or related discipline required; advanced degree preferred.
• Minimum of 6 to 8 years of regulatory affairs experience in pharmaceutical or biotech sectors, or equivalent combination with an advanced degree.
• Experience in regulatory document preparation such as INDs, DSURs, CTAs, and FDA meeting requests.
• Excellent communication, interpersonal, and teamwork skills to work with various stakeholders.
• Strong project management capabilities with ability to handle multiple concurrent projects and meet deadlines.
• Detail-oriented with strong problem analysis and critical thinking skills.
• Exceptional writing and editorial skills for producing high-quality clinical-regulatory documents including investigator brochures and briefing packets.
• Robust scientific knowledge and quick learning aptitude regarding therapeutic areas and evolving regulatory landscapes.
• Familiarity with global regulatory frameworks (FDA, ICH) and ability to keep abreast of regulatory intelligence.
• Proficient with Microsoft Office suite; experience with regulatory systems like Veeva RIM is a plus.

Additional Information

The salary range for this position in South San Francisco is expected to be between $160,000 and $185,000 annually, subject to factors such as professional experience, education, and job level. The position does not offer H-1B visa sponsorship.

ORIC Pharmaceuticals is committed to equal opportunity employment and does not discriminate based on legally protected characteristics.