DirectorAssociate Director, Regulatory Affairs

1. Support regulatory submission and strategic direction for all ORICs 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 Companys core values policies and all applicable regulations.

Qualifications :

Bachelors 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

Additional Information :

The anticipated salary range for candidates who will work on-site at our San Diego location is between $220000-$240000 for the Director level and $170000-$185000 for the Associate Director level. The final wage offered to a successful candidate will be dependent on several factors that may include title type and length of experience within the role type and length of experience within the industry education geography and other job-related factors.

ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristics.

Remote Work :

No

Employment Type :

Full-time