Director/Associate Director, Regulatory Affairs

Regulatory Jobs; San Diego (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

ORIC Pharmaceuticals is seeking a senior Regulatory Affairs professional to lead regulatory submissions for oncology programs. You will collaborate closely with regulatory operations, quality, CMC, nonclinical and clinical teams to ensure compliant, timely filings and strategic alignment with corporate goals.

The role requires 8+ years in regulatory affairs within pharma/biotech, with strong writing, communication, and leadership abilities to interact with FDA and global agencies.

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• 8+ years regulatory affairs experience in pharma/biotech.
• Experience preparing IND/DSUR/CTA and FDA meeting requests.
• Strong written and interpersonal communication with stakeholders.
• Ability to lead submissions and ensure regulatory compliance across programs.

Responsibilities

• Support regulatory submissions and provide strategic direction for development programs.
• Lead high-quality, timely regulatory submissions aligned with corporate goals and regulatory requirements.
• Coordinate regulatory activities across regulatory operations, quality, CMC, nonclinical and clinical teams.
• Create, assemble, review, and oversee complex regulatory submissions.
• Ensure submission completeness and adherence to standards.
• Represent ORIC with FDA and global regulatory agencies.
• Monitor regulatory issues and communicate intelligence internally.
• Provide strategic input on regulatory activities for product development plans.
• Develop and review SOPs to meet current regulatory requirements.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Excellent writing

Project management

Regulatory intelligence

Attention to detail

Communication skills

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Tools

Microsoft Word

Excel

PowerPoint

Job description

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

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The position is responsible for supporting and leading activities within Regulatory Affairs department, to support clinical development of oncology products at ORIC. This involves working closely with cross-functional colleagues including regulatory operations, quality, CMC, nonclinical and clinical team members. S/He will be a highly motivated team player with the ability to plan proactively, work independently, think strategically and execute assigned projects effectively.

1. Support regulatory submission and strategic direction for all ORIC's development programs.
2. Lead to deliver high quality and timely regulatory submissions in alignment with corporate goals, and in compliance with all applicable regulatory requirements.
3. Coordinate and collaborate regulatory activities across functions within ORIC, ie, regulatory operations, quality, CMC, nonclinical, clinical.
4. Responsible for the creation, assembly, review and/or oversight of complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution.
5. Ensure consistency, completeness and adherence to standards for all regulatory submissions.
6. Represent ORIC to develop and maintain strong relationships with the FDA and other global regulatory agencies.
7. Grow corporate, project and industry knowledge by reviewing and analyzing current regulatory issues, guidance, initiatives and communicating regulatory intelligence internally.
8. Participate in providing strategic input on regulatory activities in support of product development plan.
9. Participate in the development and review of standard operating procedures to ensure compliance with current regulatory requirements.

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

• Bachelor's degree in a scientific or related field, advanced degree preferred.
• At least 8+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
• Experience in preparing regulatory submissions, eg, IND, DSUR, CTA, FDA meeting request.
• Demonstration of excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
• Excellent writing and editorial skills, ability to collaborate on development of high-quality clinical-regulatory documents, eg, investigator brochures, meeting request/package.
• Strong organizational skills, with the ability to manage multiple projects simultaneously and meet deadlines.
• Strong attention to details with accuracy and quality
• A good scientific background and understanding with the ability to acquire therapy area and regulatory knowledge.
• Knowledgeable in global regulatory requirements and guidelines (eg, FDA guidance, ICH) and gathering regulatory intelligence.
• Proficient in computer literacy, eg, Microsoft Word, Excel, PowerPoint