Senior Regulatory Affairs Manager

ORIC Pharmaceuticals, Inc.; San Diego (CA); Vor Ort; USD 165.000 - 175.000; Vollzeit

Zusammenfassung

ORIC Pharmaceuticals, Inc. is seeking an experienced Regulatory Affairs professional to advance oncology product registrations.

You will collaborate across regulatory operations, quality, CMC, nonclinical and clinical teams to ensure timely, high-quality submissions and strategic guidance for U.S., EU CTIS and country-specific programs. The role requires a proactive, cross-functional team player with excellent writing and project management skills, based in San Diego, with a salary range of

Qualifikationen

• Bachelor’s degree in a scientific or related field; advanced degree preferred (MS, PhD, PharmD).
• 12 years with Bachelor’s or 8 years with MS or 5 years with PhD/PharmD.
• Experience with U.S. IND submissions, EU CTA submissions in CTIS, and outside-US CTA coordination.

Aufgaben

• Manage preparation and coordination of IND/CTA submissions (EU CTIS and country-specific).
• Prepare high-quality regulatory submissions complying with requirements.
• Provide strategic regulatory guidance for US, EU CTIS, and country CTA processes.

Kenntnisse

IND submissions

Regulatory submissions

Cross-functional collaboration

Project management

Scientific writing

Ausbildung

Bachelor’s degree in a scientific field

MS/PhD/PharmD preferred

Tools

Veeva RIM

Jobbeschreibung

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com , and follow us on X or LinkedIn .

Job Description

We are seeking an experienced Regulatory Affairs professional to join our team and help advance the clinical development of oncology products at ORIC. In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC, nonclinical and clinical functions to support high-quality, timely regulatory submissions. The ideal candidate is a proactive team player who thrives in cross-functional environments, communicates effectively, and can balance strategic thinking with strong execution.

Essential duties and responsibilities include the following. Other duties may be assigned.

• Manage the preparation and coordination of submissions to INDs or CTAs (including EU CTIS submissions and country-specific applications in regions outside the U.S.)
• Prepare and deliver high-quality and timely regulatory submissions include all required documents and are compliant with applicable regulatory requirements.
• Contribute to strategic planning for assigned programs by providing regulatory guidance on U.S., EU CTIS, and country specific CTA processes
• Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
• Responsible for the creation, assembly, review, and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution.
• Develop, manage and track regulatory submission timelines.
• Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams.
• Ensure submissions meet standards for accuracy, completeness, and consistency, and maintain health authority correspondence archives.
• Review investigator packages and support site start-up activities from regulatory perspective.
• Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively communicate regulatory intelligence internally.
• Contribute to the development and review of standard operating procedures to ensure regulatory compliance.

Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Qualifications

• Bachelor’s degree in a scientific or related field, advanced degree preferred (MS, PhD, PharmD).
• 12 years experience with Bachelor's degree -or- 8 years experience and Master's degree -or- 5 years experience and PhD/PharmD
• Demonstrated hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, outside the U.S. CTA preparation and coordination, and health authority interactions and response management
• Experience managing IND and CTA lifestyle activities (amendments, updates, and maintenance)
• Experience in preparing regulatory submissions (eg, IND, DSUR, CTA, FDA meeting requests).
• Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.
• Strong project management skills and organization skills, with ability to work independently, manage multiple projects simultaneously, and meet deadlines in a lean, fast-paced environment.
• High attention to detail, with excellent problem-solving and analytical thinking abilities.
• Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (eg, investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests).
• A strong scientific background with the ability to quickly acquire knowledge in the therapeutic areas and the evolving regulatory landscape.
• Familiarity with global regulatory requirements and guidelines (FDA, ICH), with the ability to gather and analyze latest regulatory intelligence and motivated to learn new things.
• Computer expertise, including Microsoft Office Suite proficiency (eg, Word, Excel, PowerPoint). Experience with regulatory information management system (Veeva RIM) is a plus.
• Flexible, proactive, and hands-on mindset with a can-do attitude

Additional Information

The anticipated salary range for candidates is between $165,000-$175,000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.This position is not eligible for H-1B visa sponsorship.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer.ORIC does not discriminate based onrace, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, orany other legally protected characteristic.

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